Trial Outcomes & Findings for A Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes. (NCT NCT06704178)

NCT ID: NCT06704178

Last Updated: 2025-07-24

Results Overview

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline and Month 6

Results posted on

2025-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Arm
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Overall Study
STARTED
30
30
Overall Study
COMPLETED
25
21
Overall Study
NOT COMPLETED
5
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Arm
n=30 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=30 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
13.19 years
STANDARD_DEVIATION 1.75 • n=30 Participants
12.14 years
STANDARD_DEVIATION 2.26 • n=30 Participants
12.64 years
STANDARD_DEVIATION 2.08 • n=60 Participants
Sex: Female, Male
Female
10 Participants
n=30 Participants
18 Participants
n=30 Participants
28 Participants
n=60 Participants
Sex: Female, Male
Male
20 Participants
n=30 Participants
12 Participants
n=30 Participants
32 Participants
n=60 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
30 Participants
n=30 Participants
30 Participants
n=30 Participants
60 Participants
n=60 Participants

PRIMARY outcome

Timeframe: Baseline and Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=21 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Double Trouble
168.55 percent change from baseline
Standard Deviation 230.40
129.46 percent change from baseline
Standard Deviation 332.76

PRIMARY outcome

Timeframe: Baseline and Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=21 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
IChange Mean Percentile Score in Feature Match
34.60 percent change from baseline
Standard Deviation 67.93
58.20 percent change from baseline
Standard Deviation 147.20

PRIMARY outcome

Timeframe: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=21 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Grammatical Reasoning
56.59 percent change from baseline
Standard Deviation 130.07
88.39 percent change from baseline
Standard Deviation 214.99

PRIMARY outcome

Timeframe: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=21 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Digit Span
28.02 percent change from baseline
Standard Deviation 60.29
19.69 percent change from baseline
Standard Deviation 69.38

PRIMARY outcome

Timeframe: Baseline to Month 6

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=21 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Token Search
6.26 percent change from baseline
Standard Deviation 36.38
40.20 percent change from baseline
Standard Deviation 145.02

SECONDARY outcome

Timeframe: Baseline, Month 2, Month 4, and Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=25 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Increase in Height
Month 2
0.89 percent change from baseline
Standard Deviation 4.01
1.16 percent change from baseline
Standard Deviation 6.29
Increase in Height
Month 4
3.25 percent change from baseline
Standard Deviation 4.19
1.67 percent change from baseline
Standard Deviation 4.47
Increase in Height
Month 6
3.47 percent change from baseline
Standard Deviation 5.68
3.49 percent change from baseline
Standard Deviation 4.54

SECONDARY outcome

Timeframe: Baseline, Month 2, Month 4, and Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=25 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Weight
Month 2
4.67 percent change from baseline
Standard Deviation 7.83
4.50 percent change from baseline
Standard Deviation 14.92
Changes in Weight
Month 4
5.52 percent change from baseline
Standard Deviation 5.72
2.29 percent change from baseline
Standard Deviation 6.80
Changes in Weight
Month 6
7.53 percent change from baseline
Standard Deviation 11.69
4.65 percent change from baseline
Standard Deviation 5.71

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Overall Health as Reported by Parents
Month 4
3.75 percent change from baseline
Standard Deviation 15.39
9.17 percent change from baseline
Standard Deviation 27.69
Changes in Overall Health as Reported by Parents
Month 5
1.32 percent change from baseline
Standard Deviation 15.12
17.17 percent change from baseline
Standard Deviation 40.45
Changes in Overall Health as Reported by Parents
Month 2
1.22 percent change from baseline
Standard Deviation 13.87
6.73 percent change from baseline
Standard Deviation 34.70
Changes in Overall Health as Reported by Parents
Month 3
-0.51 percent change from baseline
Standard Deviation 15.32
14.42 percent change from baseline
Standard Deviation 28.39
Changes in Overall Health as Reported by Parents
Month 1
0.45 percent change from baseline
Standard Deviation 15.09
0.19 percent change from baseline
Standard Deviation 31.04
Changes in Overall Health as Reported by Parents
Month 6
3.27 percent change from baseline
Standard Deviation 14.48
12.46 percent change from baseline
Standard Deviation 31.13

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire, with the question "I expect my child will have a very healthy life". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of the Child's Health in the Future.
Month 1
16.99 percent change from baseline
Standard Deviation 60.80
3.53 percent change from baseline
Standard Deviation 32.93
Change in Parents' Perception of the Child's Health in the Future.
Month 2
19.87 percent change from baseline
Standard Deviation 62.14
7.33 percent change from baseline
Standard Deviation 30.17
Change in Parents' Perception of the Child's Health in the Future.
Month 3
19.55 percent change from baseline
Standard Deviation 60.73
9.78 percent change from baseline
Standard Deviation 25.46
Change in Parents' Perception of the Child's Health in the Future.
Month 4
18.06 percent change from baseline
Standard Deviation 67.82
4.86 percent change from baseline
Standard Deviation 22.10
Change in Parents' Perception of the Child's Health in the Future.
Month 5
20.83 percent change from baseline
Standard Deviation 62.55
8.33 percent change from baseline
Standard Deviation 25.00
Change in Parents' Perception of the Child's Health in the Future.
Month 6
18.67 percent change from baseline
Standard Deviation 61.44
8.33 percent change from baseline
Standard Deviation 27.13

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Much worse," 5 = "Much Better"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 1
12.82 percent change from baseline
Standard Deviation 23.24
8.01 percent change from baseline
Standard Deviation 36.25
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 3
20.19 percent change from baseline
Standard Deviation 26.68
25.00 percent change from baseline
Standard Deviation 27.75
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 4
19.44 percent change from baseline
Standard Deviation 23.91
25.90 percent change from baseline
Standard Deviation 42.88
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 6
24.00 percent change from baseline
Standard Deviation 29.00
24.21 percent change from baseline
Standard Deviation 25.40
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 2
18.27 percent change from baseline
Standard Deviation 26.46
17.33 percent change from baseline
Standard Deviation 38.56
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Month 5
12.85 percent change from baseline
Standard Deviation 23.05
28.99 percent change from baseline
Standard Deviation 30.96

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Child's Energy Levels as Reported by Parents
Month 1
9.17 percent change from baseline
Standard Deviation 18.20
11.47 percent change from baseline
Standard Deviation 51.50
Change in Child's Energy Levels as Reported by Parents
Month 2
5.83 percent change from baseline
Standard Deviation 18.69
13.20 percent change from baseline
Standard Deviation 20.34
Change in Child's Energy Levels as Reported by Parents
Month 3
11.86 percent change from baseline
Standard Deviation 16.02
26.88 percent change from baseline
Standard Deviation 47.45
Change in Child's Energy Levels as Reported by Parents
Month 4
18.75 percent change from baseline
Standard Deviation 24.85
26.32 percent change from baseline
Standard Deviation 66.60
Change in Child's Energy Levels as Reported by Parents
Month 5
15.14 percent change from baseline
Standard Deviation 23.86
27.61 percent change from baseline
Standard Deviation 65.04
Change in Child's Energy Levels as Reported by Parents
Month 6
16.53 percent change from baseline
Standard Deviation 31.79
15.95 percent change from baseline
Standard Deviation 28.48

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing High-Intensity Activity
Month 4
0.00 percent change from baseline
Standard Deviation 25.54
-7.64 percent change from baseline
Standard Deviation 50.12
Changes in Limitations When Completing High-Intensity Activity
Month 6
-2.00 percent change from baseline
Standard Deviation 26.93
0.00 percent change from baseline
Standard Deviation 72.65
Changes in Limitations When Completing High-Intensity Activity
Month 1
8.33 percent change from baseline
Standard Deviation 43.27
3.85 percent change from baseline
Standard Deviation 67.22
Changes in Limitations When Completing High-Intensity Activity
Month 2
12.18 percent change from baseline
Standard Deviation 46.80
0.00 percent change from baseline
Standard Deviation 29.27
Changes in Limitations When Completing High-Intensity Activity
Month 3
6.41 percent change from baseline
Standard Deviation 46.92
-13.77 percent change from baseline
Standard Deviation 21.70
Changes in Limitations When Completing High-Intensity Activity
Month 5
6.25 percent change from baseline
Standard Deviation 49.59
-13.04 percent change from baseline
Standard Deviation 23.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing Moderate-Intensity Activity
Month 1
0.64 percent change from baseline
Standard Deviation 41.76
8.33 percent change from baseline
Standard Deviation 65.36
Changes in Limitations When Completing Moderate-Intensity Activity
Month 5
-2.08 percent change from baseline
Standard Deviation 47.73
-7.97 percent change from baseline
Standard Deviation 18.03
Changes in Limitations When Completing Moderate-Intensity Activity
Month 2
0.64 percent change from baseline
Standard Deviation 41.76
4.67 percent change from baseline
Standard Deviation 49.19
Changes in Limitations When Completing Moderate-Intensity Activity
Month 3
-3.21 percent change from baseline
Standard Deviation 36.52
-9.42 percent change from baseline
Standard Deviation 18.69
Changes in Limitations When Completing Moderate-Intensity Activity
Month 4
-10.42 percent change from baseline
Standard Deviation 20.74
-11.11 percent change from baseline
Standard Deviation 20.06
Changes in Limitations When Completing Moderate-Intensity Activity
Month 6
-10.00 percent change from baseline
Standard Deviation 20.41
-1.59 percent change from baseline
Standard Deviation 50.53

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Moving Around
Month 1
7.69 percent change from baseline
Standard Deviation 27.17
14.10 percent change from baseline
Standard Deviation 61.95
Changes in Limitations When Moving Around
Month 2
7.69 percent change from baseline
Standard Deviation 27.17
6.67 percent change from baseline
Standard Deviation 40.82
Changes in Limitations When Moving Around
Month 3
3.85 percent change from baseline
Standard Deviation 19.61
-1.45 percent change from baseline
Standard Deviation 6.95
Changes in Limitations When Moving Around
Month 4
0.00 percent change from baseline
Standard Deviation 0.00
5.56 percent change from baseline
Standard Deviation 42.47
Changes in Limitations When Moving Around
Month 5
8.33 percent change from baseline
Standard Deviation 40.82
2.90 percent change from baseline
Standard Deviation 22.28
Changes in Limitations When Moving Around
Month 6
0.00 percent change from baseline
Standard Deviation 0.00
12.70 percent change from baseline
Standard Deviation 48.85

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 1
-0.96 percent change from baseline
Standard Deviation 26.91
6.41 percent change from baseline
Standard Deviation 46.92
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 2
2.88 percent change from baseline
Standard Deviation 33.41
-1.33 percent change from baseline
Standard Deviation 25.87
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 3
-2.88 percent change from baseline
Standard Deviation 28.57
-1.45 percent change from baseline
Standard Deviation 27.02
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 4
-3.13 percent change from baseline
Standard Deviation 29.77
-1.39 percent change from baseline
Standard Deviation 26.43
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 5
1.04 percent change from baseline
Standard Deviation 46.90
-4.35 percent change from baseline
Standard Deviation 14.41
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Month 6
-7.00 percent change from baseline
Standard Deviation 19.79
14.29 percent change from baseline
Standard Deviation 63.53

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Limitations When Bending, Lifting, or Stooping.
Month 1
5.77 percent change from baseline
Standard Deviation 29.42
6.41 percent change from baseline
Standard Deviation 54.79
Change in Limitations When Bending, Lifting, or Stooping.
Month 2
3.85 percent change from baseline
Standard Deviation 31.38
0.67 percent change from baseline
Standard Deviation 34.52
Change in Limitations When Bending, Lifting, or Stooping.
Month 3
-3.85 percent change from baseline
Standard Deviation 13.59
-1.45 percent change from baseline
Standard Deviation 27.02
Change in Limitations When Bending, Lifting, or Stooping.
Month 4
-2.08 percent change from baseline
Standard Deviation 10.21
2.78 percent change from baseline
Standard Deviation 44.69
Change in Limitations When Bending, Lifting, or Stooping.
Month 5
6.25 percent change from baseline
Standard Deviation 42.51
-6.52 percent change from baseline
Standard Deviation 17.22
Change in Limitations When Bending, Lifting, or Stooping.
Month 6
-2.00 percent change from baseline
Standard Deviation 10.00
0.00 percent change from baseline
Standard Deviation 27.39

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 1
5.77 percent change from baseline
Standard Deviation 29.42
-0.96 percent change from baseline
Standard Deviation 53.56
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 2
5.77 percent change from baseline
Standard Deviation 29.42
-4.00 percent change from baseline
Standard Deviation 29.38
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 3
1.92 percent change from baseline
Standard Deviation 22.27
-5.43 percent change from baseline
Standard Deviation 30.94
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 4
-4.17 percent change from baseline
Standard Deviation 14.12
-10.42 percent change from baseline
Standard Deviation 21.88
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 5
4.17 percent change from baseline
Standard Deviation 44.03
-9.42 percent change from baseline
Standard Deviation 21.80
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Month 6
-4.00 percent change from baseline
Standard Deviation 13.84
-7.14 percent change from baseline
Standard Deviation 35.19

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 1
19.23 percent change from baseline
Standard Deviation 51.14
-5.13 percent change from baseline
Standard Deviation 56.13
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 2
0.00 percent change from baseline
Standard Deviation 24.49
-3.00 percent change from baseline
Standard Deviation 37.64
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 3
7.69 percent change from baseline
Standard Deviation 36.58
-9.78 percent change from baseline
Standard Deviation 20.82
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 4
-6.25 percent change from baseline
Standard Deviation 16.89
-10.76 percent change from baseline
Standard Deviation 23.11
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 5
2.08 percent change from baseline
Standard Deviation 45.39
-9.42 percent change from baseline
Standard Deviation 21.80
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Month 6
-6.00 percent change from baseline
Standard Deviation 16.58
-7.14 percent change from baseline
Standard Deviation 35.19

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Limitations During the Completion of Schoolwork or Activities.
Month 4
-6.25 percent change from baseline
Standard Deviation 16.89
-12.50 percent change from baseline
Standard Deviation 23.70
Change in Limitations During the Completion of Schoolwork or Activities.
Month 5
2.08 percent change from baseline
Standard Deviation 45.39
-13.04 percent change from baseline
Standard Deviation 26.09
Change in Limitations During the Completion of Schoolwork or Activities.
Month 1
5.77 percent change from baseline
Standard Deviation 29.42
-0.64 percent change from baseline
Standard Deviation 65.06
Change in Limitations During the Completion of Schoolwork or Activities.
Month 2
9.62 percent change from baseline
Standard Deviation 60.03
-2.00 percent change from baseline
Standard Deviation 37.37
Change in Limitations During the Completion of Schoolwork or Activities.
Month 3
3.85 percent change from baseline
Standard Deviation 31.38
-13.04 percent change from baseline
Standard Deviation 26.09
Change in Limitations During the Completion of Schoolwork or Activities.
Month 6
-6.00 percent change from baseline
Standard Deviation 16.58
-14.29 percent change from baseline
Standard Deviation 27.02

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 2
2.56 percent change from baseline
Standard Deviation 68.91
-4.00 percent change from baseline
Standard Deviation 32.38
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 6
0.00 percent change from baseline
Standard Deviation 43.83
8.73 percent change from baseline
Standard Deviation 52.60
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 1
-1.92 percent change from baseline
Standard Deviation 46.27
1.60 percent change from baseline
Standard Deviation 47.61
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 3
-16.67 percent change from baseline
Standard Deviation 24.49
1.45 percent change from baseline
Standard Deviation 53.16
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 4
-12.50 percent change from baseline
Standard Deviation 34.49
0.00 percent change from baseline
Standard Deviation 46.88
Change in Parents' Perception of Child's Health Compared to Other Children.
Month 5
-2.08 percent change from baseline
Standard Deviation 45.92
15.22 percent change from baseline
Standard Deviation 80.55

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Immunity
Month 5
-12.85 percent change from baseline
Standard Deviation 29.69
-3.99 percent change from baseline
Standard Deviation 31.97
Change in Parents' Perception of Child's Immunity
Month 6
-9.00 percent change from baseline
Standard Deviation 31.91
-1.98 percent change from baseline
Standard Deviation 38.54
Change in Parents' Perception of Child's Immunity
Month 1
-5.77 percent change from baseline
Standard Deviation 12.19
18.59 percent change from baseline
Standard Deviation 73.34
Change in Parents' Perception of Child's Immunity
Month 2
-11.86 percent change from baseline
Standard Deviation 21.37
1.33 percent change from baseline
Standard Deviation 25.76
Change in Parents' Perception of Child's Immunity
Month 3
-8.01 percent change from baseline
Standard Deviation 25.22
12.68 percent change from baseline
Standard Deviation 54.98
Change in Parents' Perception of Child's Immunity
Month 4
-9.72 percent change from baseline
Standard Deviation 18.17
5.56 percent change from baseline
Standard Deviation 53.26

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Worry About Child's Health
Month 1
7.37 percent change from baseline
Standard Deviation 69.77
-9.29 percent change from baseline
Standard Deviation 31.83
Change in Parents' Worry About Child's Health
Month 3
2.24 percent change from baseline
Standard Deviation 55.81
1.45 percent change from baseline
Standard Deviation 40.80
Change in Parents' Worry About Child's Health
Month 4
4.86 percent change from baseline
Standard Deviation 67.25
-1.39 percent change from baseline
Standard Deviation 48.94
Change in Parents' Worry About Child's Health
Month 2
12.18 percent change from baseline
Standard Deviation 51.71
1.33 percent change from baseline
Standard Deviation 56.91
Change in Parents' Worry About Child's Health
Month 6
1.33 percent change from baseline
Standard Deviation 52.63
-7.94 percent change from baseline
Standard Deviation 57.40
Change in Parents' Worry About Child's Health
Month 5
10.76 percent change from baseline
Standard Deviation 55.30
2.54 percent change from baseline
Standard Deviation 60.59

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Stomach Aches
Month 1
-4.49 percent change from baseline
Standard Deviation 26.48
-9.62 percent change from baseline
Standard Deviation 33.72
Change in Parent-reported Frequency of Child's Stomach Aches
Month 2
-7.69 percent change from baseline
Standard Deviation 28.37
-11.00 percent change from baseline
Standard Deviation 30.12
Change in Parent-reported Frequency of Child's Stomach Aches
Month 3
-10.26 percent change from baseline
Standard Deviation 24.98
-7.97 percent change from baseline
Standard Deviation 51.46
Change in Parent-reported Frequency of Child's Stomach Aches
Month 4
-6.25 percent change from baseline
Standard Deviation 31.40
-11.11 percent change from baseline
Standard Deviation 37.00
Change in Parent-reported Frequency of Child's Stomach Aches
Month 5
-13.19 percent change from baseline
Standard Deviation 34.40
-9.42 percent change from baseline
Standard Deviation 32.50
Change in Parent-reported Frequency of Child's Stomach Aches
Month 6
-19.33 percent change from baseline
Standard Deviation 31.80
-12.70 percent change from baseline
Standard Deviation 35.32

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=26 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
n=26 Participants
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 2
-10.19 percent change from baseline
Standard Deviation 29.11
-7.00 percent change from baseline
Standard Deviation 38.32
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 5
-17.01 percent change from baseline
Standard Deviation 36.98
-15.58 percent change from baseline
Standard Deviation 36.44
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 6
-21.00 percent change from baseline
Standard Deviation 39.32
-3.57 percent change from baseline
Standard Deviation 37.69
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 1
-6.79 percent change from baseline
Standard Deviation 28.89
-7.05 percent change from baseline
Standard Deviation 39.91
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 3
-18.21 percent change from baseline
Standard Deviation 22.79
-11.96 percent change from baseline
Standard Deviation 37.17
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Month 4
-21.53 percent change from baseline
Standard Deviation 23.30
-10.42 percent change from baseline
Standard Deviation 33.27

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
Baseline
28 percentile score
Standard Deviation 22.46
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
Month 6
48.67 percentile score
Standard Deviation 27.18

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
Baseline
39.58 percentile score
Standard Deviation 17.86
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
Month 6
45.75 percentile score
Standard Deviation 15.26

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
Baseline
47.42 percentile score
Standard Deviation 24.42
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
Month 6
56.54 percentile score
Standard Deviation 28.46

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
Baseline
42.29 percentile score
Standard Deviation 14.33
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
Month 6
50.88 percentile score
Standard Deviation 22.66

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
Baseline
53.17 percentile score
Standard Deviation 17.20
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
Month 6
53.04 percentile score
Standard Deviation 14.44

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
Month 6
49.62 percentile score
Standard Deviation 28.48
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
Baseline
33.73 percentile score
Standard Deviation 18.98

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
Baseline
40.81 percentile score
Standard Deviation 19.49
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
Month 6
45.29 percentile score
Standard Deviation 22.87

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
Baseline
47.05 percentile score
Standard Deviation 25.36
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
Month 6
54.33 percentile score
Standard Deviation 32.05

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
Baseline
52.57 percentile score
Standard Deviation 14.70
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
Month 6
57.62 percentile score
Standard Deviation 22.36

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
Baseline
48.62 percentile score
Standard Deviation 18.50
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
Month 6
55.62 percentile score
Standard Deviation 21.08

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Increase in Height - Nubest Group Only (Within-Group Analysis)
Month 4
63.33 inches
Standard Deviation 5.81
Increase in Height - Nubest Group Only (Within-Group Analysis)
Month 6
63.24 inches
Standard Deviation 4.54
Increase in Height - Nubest Group Only (Within-Group Analysis)
Baseline
61.69 inches
Standard Deviation 5.50
Increase in Height - Nubest Group Only (Within-Group Analysis)
Month 2
62.01 inches
Standard Deviation 5.82

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Increase in Height - Placebo Group Only (Within-Group Analysis)
Baseline
60.66 inches
Standard Deviation 7.07
Increase in Height - Placebo Group Only (Within-Group Analysis)
Month 2
62.41 inches
Standard Deviation 5.88
Increase in Height - Placebo Group Only (Within-Group Analysis)
Month 4
62.71 inches
Standard Deviation 5.29
Increase in Height - Placebo Group Only (Within-Group Analysis)
Month 6
63.05 inches
Standard Deviation 5.24

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

Weight measurement will be taken using a FitBit Smart Scale.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Baseline
121.68 Pounds
Standard Deviation 40.91
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Month 2
126.38 Pounds
Standard Deviation 47.81
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Month 4
124.36 Pounds
Standard Deviation 45.35
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Month 6
123.82 Pounds
Standard Deviation 34.70

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

Weight measurement will be taken using a FitBit Smart Scale.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Baseline
130.43 Pounds
Standard Deviation 50.58
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Month 2
137.92 Pounds
Standard Deviation 57.12
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Month 4
133.06 Pounds
Standard Deviation 48.91
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Month 6
128.99 Pounds
Standard Deviation 46.47

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6.

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 2
4.33 score on a scale
Standard Deviation 0.64
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 5
4.33 score on a scale
Standard Deviation 0.64
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 6
4.38 score on a scale
Standard Deviation 0.58
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Baseline
4.33 score on a scale
Standard Deviation 0.70
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 1
4.29 score on a scale
Standard Deviation 0.62
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 3
4.25 score on a scale
Standard Deviation 0.68
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 4
4.42 score on a scale
Standard Deviation 0.50

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6.

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Baseline
3.38 score on a scale
Standard Deviation 0.77
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 1
3.63 score on a scale
Standard Deviation 0.49
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 2
3.71 score on a scale
Standard Deviation 0.46
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 3
3.67 score on a scale
Standard Deviation 0.48
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 4
3.58 score on a scale
Standard Deviation 0.72
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 5
3.71 score on a scale
Standard Deviation 0.46
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Month 6
3.67 score on a scale
Standard Deviation 0.48

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6.

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 4
3.75 score on a scale
Standard Deviation 0.74
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 5
3.54 score on a scale
Standard Deviation 0.72
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Baseline
3.17 score on a scale
Standard Deviation 0.48
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 1
3.58 score on a scale
Standard Deviation 0.72
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 2
3.63 score on a scale
Standard Deviation 0.77
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 3
3.71 score on a scale
Standard Deviation 0.86
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Month 6
3.83 score on a scale
Standard Deviation 0.87

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6.

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 4
4.46 score on a scale
Standard Deviation 0.59
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Baseline
3.88 score on a scale
Standard Deviation 0.80
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 1
4.21 score on a scale
Standard Deviation 0.66
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 2
4.04 score on a scale
Standard Deviation 0.75
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 3
4.29 score on a scale
Standard Deviation 0.69
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 5
4.33 score on a scale
Standard Deviation 0.64
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Month 6
4.38 score on a scale
Standard Deviation 0.65

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Baseline
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 1
1.17 score on a scale
Standard Deviation 0.38
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 2
1.21 score on a scale
Standard Deviation 0.41
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 3
1.17 score on a scale
Standard Deviation 0.48
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 4
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 5
1.13 score on a scale
Standard Deviation 0.45
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 6
1.04 score on a scale
Standard Deviation 0.20

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 2
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Baseline
1.21 score on a scale
Standard Deviation 0.41
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 1
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 3
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Baseline
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 1
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 2
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 3
1.04 score on a scale
Standard Deviation 0.20
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Baseline
1.21 score on a scale
Standard Deviation 0.66
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 1
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 2
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 3
1.04 score on a scale
Standard Deviation 0.20
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 4
1.04 score on a scale
Standard Deviation 0.20
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Baseline
1.04 score on a scale
Standard Deviation 0.20
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 1
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 2
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 3
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Baseline
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 1
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 2
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 3
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 1
1.25 score on a scale
Standard Deviation 0.53
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Baseline
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 2
1.08 score on a scale
Standard Deviation 0.28
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 3
1.17 score on a scale
Standard Deviation 0.38
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Baseline
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 1
1.17 score on a scale
Standard Deviation 0.38
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 2
1.21 score on a scale
Standard Deviation 0.66
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 3
1.13 score on a scale
Standard Deviation 0.34
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 4
1.00 score on a scale
Standard Deviation 0.00
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 5
1.08 score on a scale
Standard Deviation 0.41
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
Month 6
1.00 score on a scale
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 4
1.33 score on a scale
Standard Deviation 0.48
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Baseline
1.71 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 1
1.46 score on a scale
Standard Deviation 0.59
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 2
1.54 score on a scale
Standard Deviation 0.83
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 3
1.29 score on a scale
Standard Deviation 0.46
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 5
1.46 score on a scale
Standard Deviation 0.51
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
Month 6
1.50 score on a scale
Standard Deviation 0.51

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 1
2.21 score on a scale
Standard Deviation 0.41
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 2
2.00 score on a scale
Standard Deviation 0.42
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Baseline
2.38 score on a scale
Standard Deviation 0.65
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 3
2.13 score on a scale
Standard Deviation 0.54
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 4
2.13 score on a scale
Standard Deviation 0.61
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 5
2.04 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
Month 6
2.08 score on a scale
Standard Deviation 0.65

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 2
2.38 score on a scale
Standard Deviation 0.65
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 3
2.13 score on a scale
Standard Deviation 0.68
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 4
2.08 score on a scale
Standard Deviation 0.58
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 5
2.33 score on a scale
Standard Deviation 0.82
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 6
2.21 score on a scale
Standard Deviation 0.78
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Baseline
2.38 score on a scale
Standard Deviation 0.92
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
Month 1
2.17 score on a scale
Standard Deviation 0.70

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 1
2.17 score on a scale
Standard Deviation 0.48
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 2
2.13 score on a scale
Standard Deviation 0.54
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 3
2.08 score on a scale
Standard Deviation 0.65
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 4
2.13 score on a scale
Standard Deviation 0.61
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 5
1.92 score on a scale
Standard Deviation 0.50
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Month 6
1.88 score on a scale
Standard Deviation 0.61
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
Baseline
2.42 score on a scale
Standard Deviation 0.72

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=24 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 1
2.13 score on a scale
Standard Deviation 0.80
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 6
1.63 score on a scale
Standard Deviation 0.58
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Baseline
2.33 score on a scale
Standard Deviation 0.92
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 2
1.96 score on a scale
Standard Deviation 0.62
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 3
1.79 score on a scale
Standard Deviation 0.66
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 4
1.71 score on a scale
Standard Deviation 0.62
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
Month 5
1.71 score on a scale
Standard Deviation 0.62

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Baseline
4.05 score on a scale
Standard Deviation 0.80
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 1
4.19 score on a scale
Standard Deviation 0.87
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 2
4.14 score on a scale
Standard Deviation 0.73
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 3
4.43 score on a scale
Standard Deviation 0.68
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 4
4.19 score on a scale
Standard Deviation 0.75
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 5
4.38 score on a scale
Standard Deviation 0.59
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 6
4.38 score on a scale
Standard Deviation 0.74

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Baseline
3.48 score on a scale
Standard Deviation 0.60
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 1
3.43 score on a scale
Standard Deviation 0.60
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 2
3.48 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 3
3.62 score on a scale
Standard Deviation 0.50
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 4
3.62 score on a scale
Standard Deviation 0.50
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 5
3.62 score on a scale
Standard Deviation 0.50
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Month 6
3.67 score on a scale
Standard Deviation 0.58

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Baseline
3.29 score on a scale
Standard Deviation 0.72
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 1
3.52 score on a scale
Standard Deviation 0.75
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 2
3.57 score on a scale
Standard Deviation 1.08
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 3
3.90 score on a scale
Standard Deviation 0.89
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 4
3.71 score on a scale
Standard Deviation 0.90
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 5
4.05 score on a scale
Standard Deviation 0.92
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
Month 6
4.05 score on a scale
Standard Deviation 0.97

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Baseline
3.86 score on a scale
Standard Deviation 0.73
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 1
3.95 score on a scale
Standard Deviation 0.67
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 2
4.29 score on a scale
Standard Deviation 0.64
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 3
4.33 score on a scale
Standard Deviation 0.66
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 4
4.10 score on a scale
Standard Deviation 0.70
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 5
4.29 score on a scale
Standard Deviation 0.72
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
Month 6
4.33 score on a scale
Standard Deviation 0.66

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Baseline
1.38 score on a scale
Standard Deviation 0.67
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 1
1.24 score on a scale
Standard Deviation 0.54
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 2
1.24 score on a scale
Standard Deviation 0.54
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 3
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 4
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 5
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 6
1.19 score on a scale
Standard Deviation 0.68

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Baseline
1.29 score on a scale
Standard Deviation 0.56
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 1
1.24 score on a scale
Standard Deviation 0.54
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 2
1.19 score on a scale
Standard Deviation 0.51
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 3
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 4
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 5
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
Month 6
1.14 score on a scale
Standard Deviation 0.48

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Baseline
1.10 score on a scale
Standard Deviation 0.44
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 1
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 2
1.10 score on a scale
Standard Deviation 0.44
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 3
1.10 score on a scale
Standard Deviation 0.44
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 4
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 5
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
Month 6
1.19 score on a scale
Standard Deviation 0.51

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Baseline
1.14 score on a scale
Standard Deviation 0.36
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 1
1.14 score on a scale
Standard Deviation 0.36
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 2
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 3
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 4
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 5
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
Month 6
1.24 score on a scale
Standard Deviation 0.62

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Baseline
1.24 score on a scale
Standard Deviation 0.70
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 1
1.14 score on a scale
Standard Deviation 0.36
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 2
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 3
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 4
1.19 score on a scale
Standard Deviation 0.51
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 5
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
Month 6
1.14 score on a scale
Standard Deviation 0.36

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 4
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 5
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 6
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Baseline
1.43 score on a scale
Standard Deviation 0.93
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 1
1.19 score on a scale
Standard Deviation 0.51
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 2
1.19 score on a scale
Standard Deviation 0.68
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
Month 3
1.14 score on a scale
Standard Deviation 0.48

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 5
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Baseline
1.43 score on a scale
Standard Deviation 0.93
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 1
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 2
1.19 score on a scale
Standard Deviation 0.51
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 3
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 4
1.14 score on a scale
Standard Deviation 0.48
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 6
1.10 score on a scale
Standard Deviation 0.30

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 1
1.24 score on a scale
Standard Deviation 0.54
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 2
1.29 score on a scale
Standard Deviation 0.64
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Baseline
1.48 score on a scale
Standard Deviation 0.87
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 3
1.10 score on a scale
Standard Deviation 0.44
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 4
1.10 score on a scale
Standard Deviation 0.30
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 5
1.05 score on a scale
Standard Deviation 0.22
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
Month 6
1.05 score on a scale
Standard Deviation 0.22

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 3
1.43 score on a scale
Standard Deviation 0.60
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 4
1.48 score on a scale
Standard Deviation 0.60
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Baseline
1.48 score on a scale
Standard Deviation 0.60
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 1
1.57 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 2
1.38 score on a scale
Standard Deviation 0.59
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 5
1.52 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
Month 6
1.43 score on a scale
Standard Deviation 0.60

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Baseline
2.24 score on a scale
Standard Deviation 0.89
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 1
2.24 score on a scale
Standard Deviation 0.62
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 2
2.19 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 3
2.19 score on a scale
Standard Deviation 0.75
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 4
2.14 score on a scale
Standard Deviation 0.73
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 5
2.00 score on a scale
Standard Deviation 0.71
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
Month 6
2.05 score on a scale
Standard Deviation 0.86

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Baseline
2.24 score on a scale
Standard Deviation 0.89
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 1
2.19 score on a scale
Standard Deviation 1.03
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 2
2.10 score on a scale
Standard Deviation 1.00
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 3
2.19 score on a scale
Standard Deviation 1.03
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 4
2.14 score on a scale
Standard Deviation 1.01
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 5
2.05 score on a scale
Standard Deviation 0.80
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
Month 6
1.90 score on a scale
Standard Deviation 1.09

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Baseline
2.24 score on a scale
Standard Deviation 0.77
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 1
2.05 score on a scale
Standard Deviation 0.74
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 2
1.90 score on a scale
Standard Deviation 0.70
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 3
1.81 score on a scale
Standard Deviation 0.75
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 4
1.90 score on a scale
Standard Deviation 1.00
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 5
1.86 score on a scale
Standard Deviation 0.79
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
Month 6
1.81 score on a scale
Standard Deviation 0.68

SECONDARY outcome

Timeframe: Monthly from Baseline to Month 6

Population: Within-group analysis. No between-group comparison reported for this outcome.

This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.

Outcome measures

Outcome measures
Measure
Intervention Arm
n=21 Participants
Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30).
Placebo Arm
Participants in this arm will take a placebo product daily for 6 months (n=30).
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Baseline
1.90 score on a scale
Standard Deviation 0.94
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 1
1.81 score on a scale
Standard Deviation 0.75
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 2
1.71 score on a scale
Standard Deviation 0.72
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 3
1.52 score on a scale
Standard Deviation 0.68
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 4
1.57 score on a scale
Standard Deviation 0.68
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 5
1.48 score on a scale
Standard Deviation 0.75
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
Month 6
1.67 score on a scale
Standard Deviation 0.73

Adverse Events

Intervention Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patrick Renner

Citruslabs

Phone: +1 805-876-4484

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place