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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey Protein Supplement | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated VO2max | Measured via 1.5-mile run time with participants running as quickly as they can. | Measured at baseline and post-intervention (10-12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at baseline and post-intervention (10-12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fat Free Mass | Measured via BodPod to assess the amount of fat-free mass each participant has (kg) | Measured at baseline and post-intervention (10-12-weeks) |
| Changes in Fat Mass | Measured via BodPod to assess the amount of fat mass each participant has (kg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Halliday, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grace Zimmerman | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41713391 | Derived | 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. |
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Request for deidentified data can be made to the PI on a case-by-case basis.
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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.
Participants (13-18 years old) were recruited from Marsh Valley High School boys and girls' soccer teams in July of 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adolescent athletes
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Carbohydrate Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated VO2max | Measured via 1.5-mile run time with participants running as quickly as they can. | 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. | Posted | Mean | Standard Error | ml/kg/min | Measured at baseline and post-intervention (10-12-weeks) |
|
Week 6 to week 10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset stomach/nausea from carbohydrate placebo | Gastrointestinal disorders | Systematic Assessment | Event was assessed via questionnaire, but the adverse event WAS NOT related to receiving the intervention. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Zimmerman | University of Utah | 7208808077 | gazimmerman@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2024 | Feb 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2022 | Feb 12, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Carbohydrate Placebo Control | Dietary Supplement | 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. |
|
|
| Changes in Speed | Measured using a 30 yard sprint | Measured at baseline and post-intervention (10-12-weeks) |
| Changes in Muscular Strength | This outcome is measured via maximum voluntary contraction from an isometric mid-thigh pull. | Measured at baseline and post-intervention (10-12-weeks) |
| Measured at baseline and post-intervention (10-12-weeks) |
| 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. | Measured at baseline and post-intervention (10-12-weeks) |
| Sleep Duration | Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep. | Measured at baseline and post-intervention (10-12-weeks) |
| Changes in Adiponectin | Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation | Measured at baseline and post-intervention (10-12-weeks) |
| Changes in BDNF | Measured via blood sample | Measured at baseline and post-intervention (10-12-weeks) |
| Changes in Follistatin | Measured via blood sample to assess muscle hypertrophy | Measured at baseline and post-intervention (10-12-weeks) |
| 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. | Measured at baseline and post-intervention (10-12-weeks) |
| Protein Intake | Measured via a 3-day food recall | Measured at baseline and post-intervention (10-12-weeks) |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | percentile |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Secondary | 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). | Posted | Mean | Standard Error | Repetitions | Measured at baseline and post-intervention (10-12-weeks) |
|
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| Secondary | Changes in Speed | Measured using a 30 yard sprint | Posted | Mean | Standard Error | seconds | Measured at baseline and post-intervention (10-12-weeks) |
|
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|
|
| Secondary | Changes in Muscular Strength | This outcome is measured via maximum voluntary contraction from an isometric mid-thigh pull. | 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. | Posted | Mean | Standard Error | Newton-meter (N·m) | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Changes in Fat Free Mass | Measured via BodPod to assess the amount of fat-free mass each participant has (kg) | Posted | Mean | Standard Error | kg | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Changes in Fat Mass | Measured via BodPod to assess the amount of fat mass each participant has (kg) | Posted | Mean | Standard Error | kg | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | 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. | Posted | Mean | Standard Error | percent | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Sleep Duration | Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep. | Posted | Mean | Standard Error | hours | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Changes in Adiponectin | Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation | Posted | Mean | Standard Error | pg/mL | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Changes in BDNF | Measured via blood sample | Posted | Mean | Standard Error | pg/mL | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Changes in Follistatin | Measured via blood sample to assess muscle hypertrophy | Posted | Mean | Standard Error | pg/mL | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | 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. | Posted | Mean | Standard Error | Scores on a scale | Measured at baseline and post-intervention (10-12-weeks) |
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| Other Pre-specified | Protein Intake | Measured via a 3-day food recall | Posted | Mean | Standard Error | g/kg/day | Measured at baseline and post-intervention (10-12-weeks) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 1 | 12 |
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| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |