Body Weight ChangesNCT05589129
Whey Protein Supplementation in High School Athletes
A study testing Whey Protein Supplement in people with Body Weight Changes and Athletic Performance, run by University of Utah at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Athletic Performance, Recovery
- What is being tested?
- Whey Protein Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 years old; male and female High school soccer players
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season
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.
- Conditions
- Body Weight Changes, Athletic Performance, Recovery, Sleep
- Being tested
- Whey Protein Supplement, Carbohydrate Placebo Control
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein SupplementDietary supplement
Also called Optimum Nutrition Gold Standard 100% Whey
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.
Carbohydrate Placebo ControlDietary supplement
Also called Nesquik Chocolate Powder
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Whey Protein Supplement |
| 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. Receives: Dietary Supplement: Carbohydrate Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated VO2max
Measured via 1.5-mile run time with participants running as quickly as they can.
Measured: Measured at baseline and post-intervention (10-12-weeks)
Secondary outcomes (3)
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: Measured at baseline and post-intervention (10-12-weeks)
Changes in Speed
Measured using a 30 yard sprint
Measured: 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: Measured at baseline and post-intervention (10-12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start14 Jul 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Halliday, University of Utah
- Investigators
- Tanya Halliday, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589129
- Sponsor's protocol ID
- 00145632
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2022
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Request for deidentified data can be made to the PI on a case-by-case basis.
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 at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season
- ClinicalTrials.gov ID
- NCT05589129
- Acronym / sponsor ID
- 00145632
- Conditions
- Body Weight Changes, Athletic Performance, Recovery, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Supplement | Experimental | Dietary Supplement: Whey Protein SupplementWhey 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 | Dietary Supplement: Carbohydrate Placebo ControlCarbohydrate 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 13-18 years old; male and female High school soccer players
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein SupplementAlso: Optimum Nutrition Gold Standard 100% WheyParticipants 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. | Dietary supplement | Whey Protein Supplement |
| Carbohydrate Placebo ControlAlso: Nesquik Chocolate PowderParticipants 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. | Dietary supplement | Carbohydrate Control |
Primary outcome
Estimated VO2max
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Measured via 1.5-mile run time with participants running as quickly as they can.
3 secondary outcomes
Changes in Muscular Fatigue Via Repetitions to Fatigue
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Changes in Speed
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Changes in Muscular Strength
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41713391Zimmerman 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.
- Individual participant dataSharing planned: No. Request for deidentified data can be made to the PI on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Halliday, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Supplement in people with Body Weight Changes and Athletic Performance, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated VO2max (time frame: Measured at baseline and post-intervention (10-12-weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.