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CompletedNCT05589129Updated Apr 27, 2026Results posted

Whey Protein Supplementation in High School Athletes

An interventional study of Whey Protein Supplement and Carbohydrate Placebo Control in Body Weight Changes, Athletic Performance and Recovery, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by University of Utah · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study summary

The overall aim of this project is to compare protein supplementation on performance, recovery, and body composition changes in adolescent soccer players between the whey protein and the control group in response to the 10-12-week intervention.

Read the detailed description

Informed Consent, Parental Permission and Assent: These will be obtained over Zoom, prior to participation in any study procedures.

Randomization: Randomization will occur following baseline testing. Participants will be randomized via random number generator stratified by sex, into either the whey protein supplement group or the placebo (isocaloric) control group.

Baseline and Post-Intervention testing will occur over a single day for each participant.

Baseline:

All athletes will report to testing facilities for a single blood draw to measure inflammatory biomarkers and a body composition assessment (via BodPod) to measure fat mass and fat free mass. Participants will then be escorted to a track where they will run a 30-yard dash to assess their speed and a 1.5-mile run to assess their estimated maximal rate of oxygen consumption (VO2max). Participants will then be transferred back to the testing facility where they will undergo assessment of lower body muscle fatigue (via HumacNorm).

Questionnaires: Athletes will complete the Munich Chronotype Questionnaire and the Pittsburg Sleep Quality Index (PSQI). Participants will also complete 3-day, 24-hour dietary recalls (via ASA-24).

Sleep measures: Fitbit (Inspire 2) will be used measure sleep efficiency, duration, and staging. Fitabase will be utilized to receive Fitbit data. Participants will be instructed to wear their Fitbit for 1-week.

Intervention:

In-season soccer practices and competition will occur 6-days per week across a 10-12 week period, depending on how far teams advance in postseason play. During the 10-12-weeks, participants will consume their assigned supplement or placebo twice per day, every day, immediately after practice or competition (or midday on rest days), and \~1 hour before bedtime.

Sleep measures: Sleep measures will be evaluated as described above. Sleep measures will be collected at weeks 2, 4, 6, 8, and 10.

Questionnaires: Participants will complete 3-days of 24-hour dietary recalls (via ASA-24) at weeks 5 and 10. Pittsburg Sleep Quality Index (PSQI), a delayed-onset muscle soreness questionnaire and a GI symptom Questionnaire will be completed at weeks 2, 4, 6, 8 and 10.

Urine Samples: We will randomly assign participants to provide urine samples at weeks 4 and 7 as a sham measure of compliance to supplementation protocol.

Post-testing will be the same as pre-testing and will commence after the 10-12-week competitive season. All measures described above in baseline testing will be repeated.

02

Conditions studied

  • Body Weight Changes
  • Athletic Performance
  • Recovery
  • Sleep

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03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's enrollment of 31 is below the median of 80 across 179 interventional studies indexed under Body Weight Changes.

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Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 13-18 years old; male and female High school soccer players

Exclusion criteria

Exclusion Criteria:

  • non-adolescents; untreated or underlying metabolic or cardiovascular diseases; allergies to dairy, or any allergies ingredients in the study provided granola bar or bagels, such as soy, wheat, tree nuts, peanuts, milk, and sesame.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    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.

    Dietary Supplement: Whey Protein Supplement

  • Placebo comparator
    Carbohydrate Control

    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.

    Dietary Supplement: Carbohydrate Placebo Control

Interventions

  • Dietary supplementWhey Protein Supplement

    Participants assigned to the intervention will consume the supplement mixed with 6-8oz of water every day, twice per day, after soccer practice or soccer games, and one hour before bedtime.

    Also known as: Optimum Nutrition Gold Standard 100% Whey

  • Dietary supplementCarbohydrate Placebo Control

    Participants assigned to the placebo control will consume the supplement mixed with 6-8oz of water every day, twice per day, after soccer practice or soccer games, and one hour before bedtime.

    Also known as: Nesquik Chocolate Powder

06

What researchers measure

Primary outcomes

  1. Estimated VO2max

    Measured via 1.5-mile run time with participants running as quickly as they can.

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

Secondary outcomes

  1. Changes in Muscular Fatigue Via Repetitions to Fatigue

    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).

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  2. Changes in Speed

    Measured using a 30 yard sprint

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  3. Changes in Muscular Strength

    This outcome is measured via maximum voluntary contraction from an isometric mid-thigh pull.

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

Other outcomes

  1. Changes in Fat Free Mass

    Measured via BodPod to assess the amount of fat-free mass each participant has (kg)

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  2. Changes in Fat Mass

    Measured via BodPod to assess the amount of fat mass each participant has (kg)

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  3. Sleep Efficiency

    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.

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  4. Sleep Duration

    Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep.

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  5. Changes in Adiponectin

    Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  6. Changes in BDNF

    Measured via blood sample

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  7. Changes in Follistatin

    Measured via blood sample to assess muscle hypertrophy

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  8. Changes in Sleep Quality

    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.

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

  9. Protein Intake

    Measured via a 3-day food recall

    Time frame: Measured at baseline and post-intervention (10-12-weeks)

07

Results

Posted Apr 27, 2026
Limitations and caveats
Self-reported compliance with the supplementation protocol may have influenced overall findings. Due to the location of the high school (two hours from campus) and IRB restrictions that prevented coaching or athletic training staff from directly monitoring supplement intake, adherence monitoring was conducted remotely via twice-daily text messaging.

Participant flow

Participants (13-18 years old) were recruited from Marsh Valley High School boys and girls' soccer teams in July of 2022.

Participant flow — Overall Study
MilestoneWhey Protein SupplementCarbohydrate Control
Started1515
Completed1012
Not completed53

Outcome measures

PrimaryEstimated VO2max

Measured via 1.5-mile run time with participants running as quickly as they can.

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · ml/kg/min
Estimated VO2max
ml/kg/minWhey Protein SupplementCarbohydrate Control
Baseline43.8 ± 2.4142.0 ± 1.51
Post-intervention47.9 ± 2.5244.5 ± 1.64
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.04
SecondaryChanges in Muscular Fatigue Via Repetitions to Fatigue

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).

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · Repetitions
Changes in Muscular Fatigue Via Repetitions to Fatigue
RepetitionsWhey Protein SupplementCarbohydrate Control
Baseline10 ± 0.886.58 ± 0.51
Post-intervention8.3 ± 1.17.2 ± 0.84
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.02
SecondaryChanges in Speed

Measured using a 30 yard sprint

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · seconds
Changes in Speed
secondsWhey Protein SupplementCarbohydrate Control
Baseline4.9 ± 0.134.99 ± 0.11
Post-intervention4.73 ± 14.8 ± 0.12
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.85
SecondaryChanges in Muscular Strength

This outcome is measured via maximum voluntary contraction from an isometric mid-thigh pull.

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · Newton-meter (N·m)
Changes in Muscular Strength
Newton-meter (N·m)Whey Protein SupplementCarbohydrate Control
Baseline168 ± 15.3171 ± 9.4
Post-intervention172 ± 12.8164 ± 10.2
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.34
Other pre-specifiedChanges in Fat Free Mass

Measured via BodPod to assess the amount of fat-free mass each participant has (kg)

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · kg
Changes in Fat Free Mass
kgWhey Protein SupplementCarbohydrate Control
Baseline46.7 ± 2.346.1 ± 1.2
Post-intervention47.5 ± 2.446.9 ± 1.8
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.85
Other pre-specifiedChanges in Fat Mass

Measured via BodPod to assess the amount of fat mass each participant has (kg)

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · kg
Changes in Fat Mass
kgWhey Protein SupplementCarbohydrate Control
Baseline11.7 ± 2.512.9 ± 1.6
Post-intervention11 ± 2.211.8 ± 1.2
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.68
Other pre-specifiedSleep Efficiency

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.

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · percent
Sleep Efficiency
percentWhey Protein SupplementCarbohydrate Control
Baseline92.9 ± 0.6594.1 ± 0.74
Post-intervention92.1 ± 2.394.2 ± 0.45
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.42
Other pre-specifiedSleep Duration

Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep.

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · hours
Sleep Duration
hoursWhey Protein SupplementCarbohydrate Control
Baseline7.14 ± 0.377.33 ± 0.23
Post-intervention7.31 ± 0.257.49 ± 0.73
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.29
Other pre-specifiedChanges in Adiponectin

Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · pg/mL
Changes in Adiponectin
pg/mLWhey Protein SupplementCarbohydrate Control
Baseline8333719 ± 17168997339317 ± 1039637
Post-intervention7930054 ± 15999507482251 ± 1168166
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.91
Other pre-specifiedChanges in BDNF

Measured via blood sample

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · pg/mL
Changes in BDNF
pg/mLWhey Protein SupplementCarbohydrate Control
Baseline39.8 ± 14.648.7 ± 8.0
Post-intervention51.2 ± 15.739.8 ± 9.37
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.77
Other pre-specifiedChanges in Follistatin

Measured via blood sample to assess muscle hypertrophy

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · pg/mL
Changes in Follistatin
pg/mLWhey Protein SupplementCarbohydrate Control
Baseline103 ± 18.295.7 ± 11.8
Post-intervention84.5 ± 15.877.0 ± 7.91
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.91
Other pre-specifiedChanges in Sleep Quality

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.

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · Scores on a scale
Changes in Sleep Quality
Scores on a scaleWhey Protein SupplementCarbohydrate Control
Baseline4.5 ± 0.546.67 ± 0.86
Post-intervention2.3 ± 0.585.42 ± 0.93
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.38
Other pre-specifiedProtein Intake

Measured via a 3-day food recall

Time frame:
Measured at baseline and post-intervention (10-12-weeks)
Reported as:
Mean · g/kg/day
Protein Intake
g/kg/dayWhey Protein SupplementCarbohydrate Control
Baseline1.21 ± 0.191.37 ± 0.21
Post-intervention1.52 ± 0.321.29 ± 0.12
Statistical analysis
  • Whey Protein Supplement vs Carbohydrate Control · Regression, Linear · p = =0.42

Adverse events

Collected over Week 6 to week 10. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Whey Protein Supplement0/10 (0%)0/10 (0%)0/10 (0%)
Carbohydrate Control0/12 (0%)0/12 (0%)1/12 (8.3%)
Most frequent other events
Most frequent other events
EventWhey Protein SupplementCarbohydrate Control
Upset stomach/nausea from carbohydrate placeboGastrointestinal disorders0/101/12

Baseline characteristics

Adolescent athletes

Age, Continuous
Age, Continuous(years)Whey Protein SupplementCarbohydrate ControlTotal
Mean15.4 ± 0.4015.8 ± 0.3015.6 ± 0.30
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Whey Protein SupplementCarbohydrate ControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White101222
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Whey Protein SupplementCarbohydrate ControlTotal
United States101222
Body mass index
Body mass index(percentile)Whey Protein SupplementCarbohydrate ControlTotal
Mean53.9 ± 33.652.9 ± 28.453.4 ± 30.1
Sex: Female, Male
Sex: Female, Male(Participants)Whey Protein SupplementCarbohydrate ControlTotal
Female5813
Male549
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Whey Protein SupplementCarbohydrate ControlTotal
Hispanic or Latino000
Not Hispanic or Latino101222
Unknown or Not Reported000
08

Study locations

1 site
  • Grace Zimmerman
    Salt Lake City, Utah 84112, United States
09

References and documents

Publications

  • Zimmerman G, Mmp de Hart N, Ou I, Miranda V, Bastian E, Drummond M, Depner C, Halliday T. The effects of whey protein supplementation on athletic performance and body composition in adolescent soccer players: a randomized controlled trial. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-9. doi: 10.1139/apnm-2025-0325. PubMed 41713391 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Request for deidentified data can be made to the PI on a case-by-case basis.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05589129
Lead sponsor
University of Utah
Responsible party
Tanya Halliday (Principal Investigator, PhD, University of Utah) — Principal investigator
First posted
Oct 21, 2022
Start date
Jul 14, 2022
Primary completion
Oct 28, 2022
Completion
Oct 28, 2022
Results posted
Apr 27, 2026
Last update
Apr 27, 2026

Study contacts

Tanya Halliday, PhD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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