Whey Protein Supplementation in High School Athletes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Body Weight Changes, Athletic Performance, Recovery, Sleep

Intervention / Treatment
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* Dietary Supplement: Whey Protein Supplement
* Dietary Supplement: Carbohydrate Placebo Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey Protein Supplement<br>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<br>* 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.<br>* Other names: Optimum Nutrition Gold Standard 100% Whey;|
| Placebo Comparator: Carbohydrate Control<br>Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquick Chocolate Powder mix. | Dietary Supplement: Carbohydrate Placebo Control<br>* 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.<br>* Other names: Nesquik Chocolate Powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fat Free Mass | Measured via BodPod | Measured at baseline and post-intervention (10-12-weeks) | 
| Changes in Fat Mass | Measured via BodPod | Measured at baseline and post-intervention (10-12-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Cardiorespiratory Fitness (V02max) | Measured via 1.5-mile run time | Measured at baseline and post-intervention (10-12-weeks) | 
| Changes in Muscular Fatigue | Measured via leg extension machine (HumacNorm) using isometric muscle contraction in the quadriceps muscle. | 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, 2-, 4-, 6-, 8-weeks 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, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks) | 
| Changes in Speed | 30 yard sprint | Measured at baseline and post-intervention (10-12-weeks) | 
| Sleep Staging | Measured via Fitbit devices. Sleep stages are different periods of sleep where muscle tone and heart rate vary. | Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks) |