Trial Outcomes & Findings for Whey Protein Supplementation in High School Athletes (NCT NCT05589129)
NCT ID: NCT05589129
Last Updated: 2026-04-27
Results Overview
Measured via 1.5-mile run time with participants running as quickly as they can.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Measured at baseline and post-intervention (10-12-weeks)
Results posted on
2026-04-27
Participant Flow
Participants (13-18 years old) were recruited from Marsh Valley High School boys and girls' soccer teams in July of 2022.
Participants completed baseline testing after receiving written informed consent and assent. Participants were randomized to consuming whey protein or placebo. One participant withdrew before starting intervention.
Participant milestones
| Measure |
Whey Protein Supplement
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 27.1g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whey Protein Supplementation in High School Athletes
Baseline characteristics by cohort
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=226 Participants
|
12 Participants
n=240 Participants
|
22 Participants
n=236 Participants
|
|
Age, Continuous
|
15.4 years
STANDARD_DEVIATION 0.40 • n=226 Participants
|
15.8 years
STANDARD_DEVIATION 0.30 • n=240 Participants
|
15.6 years
STANDARD_DEVIATION 0.30 • n=236 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=226 Participants
|
12 Participants
n=240 Participants
|
22 Participants
n=236 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=226 Participants
|
12 Participants
n=240 Participants
|
22 Participants
n=236 Participants
|
|
Body mass index
|
53.9 percentile
STANDARD_DEVIATION 33.6 • n=226 Participants
|
52.9 percentile
STANDARD_DEVIATION 28.4 • n=240 Participants
|
53.4 percentile
STANDARD_DEVIATION 30.1 • n=236 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=226 Participants
|
8 Participants
n=240 Participants
|
13 Participants
n=236 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=226 Participants
|
4 Participants
n=240 Participants
|
9 Participants
n=236 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Population: There were 10 in the Whey Protein Supplement as a result of participants dropping out, and there were 12 in Carbohydrate Control group as a result of participants dropping out.
Measured via 1.5-mile run time with participants running as quickly as they can.
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Estimated VO2max
Baseline
|
43.8 ml/kg/min
Standard Error 2.41
|
42.0 ml/kg/min
Standard Error 1.51
|
|
Estimated VO2max
Post-intervention
|
47.9 ml/kg/min
Standard Error 2.52
|
44.5 ml/kg/min
Standard Error 1.64
|
SECONDARY outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via leg extension machine (HumacNorm) using isometric muscle contraction in the quadriceps muscle. Repetitions to fatigue was defined as the total number of consecutive maximal isometric contractions completed until force output declines below a predetermined threshold (e.g., \<45% of peak torque).
Outcome measures
| Measure |
Whey Protein Supplement
n=12 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=10 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Muscular Fatigue Via Repetitions to Fatigue
Post-intervention
|
8.3 Repetitions
Standard Error 1.1
|
7.2 Repetitions
Standard Error 0.84
|
|
Changes in Muscular Fatigue Via Repetitions to Fatigue
Baseline
|
10 Repetitions
Standard Error 0.88
|
6.58 Repetitions
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured using a 30 yard sprint
Outcome measures
| Measure |
Whey Protein Supplement
n=12 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=10 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Speed
Baseline
|
4.9 seconds
Standard Error 0.13
|
4.99 seconds
Standard Error 0.11
|
|
Changes in Speed
Post-intervention
|
4.73 seconds
Standard Error 1
|
4.8 seconds
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Population: There were 10 in the Whey Protein Supplement as a result of participants dropping out, and there were 12 in Carbohydrate Control group as a result of participants dropping out.
This outcome is measured via maximum voluntary contraction from an isometric mid-thigh pull.
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Muscular Strength
Post-intervention
|
172 Newton-meter (N·m)
Standard Error 12.8
|
164 Newton-meter (N·m)
Standard Error 10.2
|
|
Changes in Muscular Strength
Baseline
|
168 Newton-meter (N·m)
Standard Error 15.3
|
171 Newton-meter (N·m)
Standard Error 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via BodPod to assess the amount of fat-free mass each participant has (kg)
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Fat Free Mass
Baseline
|
46.7 kg
Standard Error 2.3
|
46.1 kg
Standard Error 1.2
|
|
Changes in Fat Free Mass
Post-intervention
|
47.5 kg
Standard Error 2.4
|
46.9 kg
Standard Error 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via BodPod to assess the amount of fat mass each participant has (kg)
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Fat Mass
Baseline
|
11.7 kg
Standard Error 2.5
|
12.9 kg
Standard Error 1.6
|
|
Changes in Fat Mass
Post-intervention
|
11 kg
Standard Error 2.2
|
11.8 kg
Standard Error 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via Fitbit devices. Sleep efficiency is measured based on how long and individual is asleep over the time spent in bed during the night.
Outcome measures
| Measure |
Whey Protein Supplement
n=6 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=7 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Sleep Efficiency
Baseline
|
92.9 percent
Standard Error 0.65
|
94.1 percent
Standard Error 0.74
|
|
Sleep Efficiency
Post-intervention
|
92.1 percent
Standard Error 2.3
|
94.2 percent
Standard Error 0.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep.
Outcome measures
| Measure |
Whey Protein Supplement
n=6 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=7 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Sleep Duration
Baseline
|
7.14 hours
Standard Error 0.37
|
7.33 hours
Standard Error 0.23
|
|
Sleep Duration
Post-intervention
|
7.31 hours
Standard Error 0.25
|
7.49 hours
Standard Error 0.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Adiponectin
Baseline
|
8333719 pg/mL
Standard Error 1716899
|
7339317 pg/mL
Standard Error 1039637
|
|
Changes in Adiponectin
Post-intervention
|
7930054 pg/mL
Standard Error 1599950
|
7482251 pg/mL
Standard Error 1168166
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via blood sample
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in BDNF
Baseline
|
39.8 pg/mL
Standard Error 14.6
|
48.7 pg/mL
Standard Error 8.0
|
|
Changes in BDNF
Post-intervention
|
51.2 pg/mL
Standard Error 15.7
|
39.8 pg/mL
Standard Error 9.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via blood sample to assess muscle hypertrophy
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Follistatin
Baseline
|
103 pg/mL
Standard Error 18.2
|
95.7 pg/mL
Standard Error 11.8
|
|
Changes in Follistatin
Post-intervention
|
84.5 pg/mL
Standard Error 15.8
|
77.0 pg/mL
Standard Error 7.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via Pittsburgh Sleep Quality Index questionnaire. The questionnaire consists of a combination of Likerttype and open-ended questions. Each component is scored from 0 to 3, with higher scores indicating greater sleep disturbance or poorer sleep quality. Component scores are summed to yield a global PSQI score ranging from 0 to 21. A global PSQI score \>5 is commonly used to indicate poor sleep quality, whereas scores ≤5 indicate relatively good sleep quality. Each component is scored from 0 to 3, with higher scores indicating greater sleep disturbance or poorer sleep quality. Component scores are summed to yield a global PSQI score ranging from 0 to 21.
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Changes in Sleep Quality
Baseline
|
4.5 Scores on a scale
Standard Error 0.54
|
6.67 Scores on a scale
Standard Error 0.86
|
|
Changes in Sleep Quality
Post-intervention
|
2.3 Scores on a scale
Standard Error 0.58
|
5.42 Scores on a scale
Standard Error 0.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and post-intervention (10-12-weeks)Measured via a 3-day food recall
Outcome measures
| Measure |
Whey Protein Supplement
n=10 Participants
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 Participants
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Protein Intake
Baseline
|
1.21 g/kg/day
Standard Error 0.19
|
1.37 g/kg/day
Standard Error 0.21
|
|
Protein Intake
Post-intervention
|
1.52 g/kg/day
Standard Error 0.32
|
1.29 g/kg/day
Standard Error 0.12
|
Adverse Events
Whey Protein Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carbohydrate Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Whey Protein Supplement
n=10 participants at risk
Whey protein will come in powder form and will consist of 20g of protein, and 25.3g of product. We will use Optimum Nutrition Double Chocolate Whey Protein Isolate.
|
Carbohydrate Control
n=12 participants at risk
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
|
|---|---|---|
|
Gastrointestinal disorders
Upset stomach/nausea from carbohydrate placebo
|
0.00%
0/10 • Week 6 to week 10
|
8.3%
1/12 • Number of events 3 • Week 6 to week 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place