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Completed

NCT Number: NCT05589129

Whey Protein Supplementation in High School Athletes

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grace Zimmerman

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

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.

Other names: Optimum Nutrition Gold Standard 100% Whey

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.

Other names: Nesquik Chocolate Powder

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in Muscular Fatigue Via Repetitions to Fatigue

    Time frame: 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).

  2. Changes in Speed

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

    Measured using a 30 yard sprint

  3. Changes in Muscular Strength

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

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

Other outcomes

  1. Changes in Fat Free Mass

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

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

  2. Changes in Fat Mass

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

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

  3. Sleep Efficiency

    Time frame: 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.

  4. Sleep Duration

    Time frame: 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.

  5. Changes in Adiponectin

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

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

  6. Changes in BDNF

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

    Measured via blood sample

  7. Changes in Follistatin

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

    Measured via blood sample to assess muscle hypertrophy

  8. Changes in Sleep Quality

    Time frame: 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.

  9. Protein Intake

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

    Measured via a 3-day food recall

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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