Trial Outcomes & Findings for Shifting Salty Taste Preferences in Children (NCT NCT02909764)

NCT ID: NCT02909764

Last Updated: 2019-09-30

Results Overview

Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) . The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations. Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better. Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated a, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Baseline (time 0) and after 8-week intervention

Results posted on

2019-09-30

Participant Flow

Mothers were recruited from a list of past participants in our research program who asked to be contacted for future studies. Study was conducted at The Monell Chemical Senses Center in Philadelphia, Pennsylvania USA in 2016.

Children were randomized at the beginning of the first test session. There were no significant effects that occurred after participant enrollment but before randomization to study group.

Participant milestones

Participant milestones
Measure
Control Group [Regular Sodium Group]
Children will receive regularly salted cereal to consume 4 times per week over an 8-week (2-month) period.
Low Sodium Group
Intervention: Children will receive low sodium cereal to consume 4 times per week over an 8-week (2-month) period. Low Sodium Group: Breakfast Cereal
Overall Study
STARTED
19
20
Overall Study
COMPLETED
19
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shifting Salty Taste Preferences in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Total
n=39 Participants
Total of all reporting groups
Age, Continuous
11.4 years
STANDARD_DEVIATION 2.3 • n=99 Participants
11.3 years
STANDARD_DEVIATION 2.2 • n=107 Participants
11.3 years
STANDARD_DEVIATION 2.2 • n=206 Participants
Sex: Female, Male
Female
13 Participants
n=99 Participants
13 Participants
n=107 Participants
26 Participants
n=206 Participants
Sex: Female, Male
Male
6 Participants
n=99 Participants
7 Participants
n=107 Participants
13 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=99 Participants
16 Participants
n=107 Participants
26 Participants
n=206 Participants
Race (NIH/OMB)
White
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=99 Participants
2 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline (time 0) and after 8-week intervention

Population: Some children did not understand the task and responded at random.

Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) . The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations. Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better. Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated a, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Most Preferred Level of Salt Taste
Baseline
0.44 mol/L
Standard Error 0.04
0.34 mol/L
Standard Error 0.04
Most Preferred Level of Salt Taste
After 8-week intervention
0.42 mol/L
Standard Error 0.05
0.43 mol/L
Standard Error 0.05

PRIMARY outcome

Timeframe: At baseline and after 8-week intervention

The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Relative Preference for Regular vs Low Sodium Cereal
Baseline, Number preferred low salt cereal
3 Participants
5 Participants
Relative Preference for Regular vs Low Sodium Cereal
End Intervention, Number preferred low salt cereal
7 Participants
4 Participants

SECONDARY outcome

Timeframe: Baseline and after 8-week intervention

Population: Some children did not understand or complete the task.

Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Salt Taste Detection Thresholds
Baseline
4.4 mol x 10-3/L
Standard Error 0.8
3.6 mol x 10-3/L
Standard Error 0.8
Salt Taste Detection Thresholds
After 8-week Exposure Period
4.6 mol x 10-3/L
Standard Error 1.0
5.4 mol x 10-3/L
Standard Error 1.1

SECONDARY outcome

Timeframe: At baseline and after 8-week intervention

Children were presented with pairs of sucrose solutions of varying concentrations (0.09, 0.18, 0.35, 0.70, 1.05 M). The first pair presented were from the middle range of concentrations. Children tasted each sample and then pointed to the sample they liked better. Each subsequent pair of samples presented contained the concentration selected by the child paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated after a 3-minute break, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine the most preferred levels of sucrose.

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Most Preferred Level of Sucrose
After 8-week intervention
0.76 mol/L
Standard Error 0.06
0.64 mol/L
Standard Error 0.06
Most Preferred Level of Sucrose
Baseline
0.72 mol/L
Standard Error 0.07
0.57 mol/L
Standard Error 0.07

SECONDARY outcome

Timeframe: 28 days

Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=19 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Intake of Cereal During Intervention Period
Intake, Day 26
23.5 grams
Standard Error 4.7
13.7 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 1
27.8 grams
Standard Error 4.3
19.3 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 2
33.3 grams
Standard Error 4.3
17.9 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 3
30.6 grams
Standard Error 4.3
18.9 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 4
34.8 grams
Standard Error 4.3
19.8 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 5
25.7 grams
Standard Error 4.3
20.3 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 6
27.8 grams
Standard Error 4.3
19.4 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 7
27.0 grams
Standard Error 4.3
20.3 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 8
24.9 grams
Standard Error 4.3
19.3 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 9
24.9 grams
Standard Error 4.3
16.5 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 10
23.4 grams
Standard Error 4.3
17.6 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 11
25.9 grams
Standard Error 4.3
16.5 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 12
24.5 grams
Standard Error 4.3
15.3 grams
Standard Error 4.7
Intake of Cereal During Intervention Period
Intake, Day 13
24.5 grams
Standard Error 4.3
17.7 grams
Standard Error 4.9
Intake of Cereal During Intervention Period
Intake, Day 14
24.9 grams
Standard Error 4.3
15.4 grams
Standard Error 4.9
Intake of Cereal During Intervention Period
Intake, Day 15
24.2 grams
Standard Error 4.4
19.4 grams
Standard Error 4.9
Intake of Cereal During Intervention Period
Intake, Day 16
23.2 grams
Standard Error 4.4
18.9 grams
Standard Error 5.0
Intake of Cereal During Intervention Period
Intake, Day 17
24.2 grams
Standard Error 4.7
13.9 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 18
27.0 grams
Standard Error 4.7
15.7 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 19
23.7 grams
Standard Error 4.7
12.6 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 20
21.8 grams
Standard Error 4.7
14.3 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 21
20.2 grams
Standard Error 4.7
16.4 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 22
25.9 grams
Standard Error 4.7
15.7 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 23
23.8 grams
Standard Error 4.7
12.5 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 24
23.0 grams
Standard Error 4.7
11.3 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 25
25.8 grams
Standard Error 4.7
15.7 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 27
19.0 grams
Standard Error 4.7
12.5 grams
Standard Error 5.2
Intake of Cereal During Intervention Period
Intake, Day 28
23.0 grams
Standard Error 4.7
10.7 grams
Standard Error 5.2

SECONDARY outcome

Timeframe: Baseline

Blood pressure (mmHg) was measured by using an automatic blood pressure machine with pediatric cuff. Blood pressure will be measured at baseline (time 0). There were no a priori hypothesis but were collected as baseline characteristic to ensure no differences between the groups.

Outcome measures

Outcome measures
Measure
Control Group [Regular Sodium Group]
n=18 Participants
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
Low Sodium Group
n=20 Participants
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Low Sodium Group: Breakfast Cereal
Blood Pressure
Systolic, baseline
113.7 mmHg
Standard Error 2.7
115.5 mmHg
Standard Error 2.9
Blood Pressure
Diastolic, baseline
65.1 mmHg
Standard Error 1.3
66.6 mmHg
Standard Error 1.4

Adverse Events

Control Group [Regular Sodium Group]

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

Low Sodium Group

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

Julie A. Mennella

Monell Chemical Senses Center

Phone: 2675194880

Results disclosure agreements

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