Whey Protein Supplementation in High School Athletes

Sponsor
University of Utah (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05589129
Collaborator
(none)
31
1
2
9.6
3.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whey Protein Supplement
  • Dietary Supplement: Carbohydrate Placebo Control
N/A

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

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season
Actual Study Start Date :
Jul 14, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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
  • 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 Nesquick Chocolate Powder mix.

    Dietary Supplement: Carbohydrate 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.
    Other Names:
  • Nesquik Chocolate Powder
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Fat Free Mass [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via BodPod

    2. Changes in Fat Mass [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via BodPod

    Secondary Outcome Measures

    1. Estimated Cardiorespiratory Fitness (V02max) [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via 1.5-mile run time

    2. Changes in Muscular Fatigue [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via leg extension machine (HumacNorm) using isometric muscle contraction in the quadriceps muscle.

    3. Sleep Efficiency [Measured at baseline, 2-, 4-, 6-, 8-weeks 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 [Measured at baseline, 2-, 4-, 6-, 8-weeks 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 Speed [Measured at baseline and post-intervention (10-12-weeks)]

      30 yard sprint

    6. Sleep Staging [Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)]

      Measured via Fitbit devices. Sleep stages are different periods of sleep where muscle tone and heart rate vary.

    Other Outcome Measures

    1. Changes in adiponectin [Measured at baseline and post-intervention (10-12-weeks)]

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

    2. Changes in interleukin-6 [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via blood sample to assess inflammation

    3. Changes in fibroblast growth factor 21 [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via blood sample to assess muscle hypertrophy

    4. Changes in follistatin [Measured at baseline and post-intervention (10-12-weeks)]

      Measured via blood sample to assess muscle hypertrophy

    5. Changes in delayed onset muscle soreness [Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)]

      Measured via likert scale questionnaire

    6. Changes in Sleep quality [Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)]

      Measured via Pittsburgh Sleep Quality Index questionnaire

    7. Changes in dietary habits [Measured at baseline, 5-weeks and post-intervention (10-12-weeks)]

      Measured via a 3-day food recall

    8. Sleep Chronotype [Measured at baseline.]

      Measured by the Munich Chronotype Questionnaire to evaluate the morningness-eveningness of participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Grace Zimmerman Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • University of Utah

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tanya Halliday, PhD, University of Utah
    ClinicalTrials.gov Identifier:
    NCT05589129
    Other Study ID Numbers:
    • 00145632
    First Posted:
    Oct 21, 2022
    Last Update Posted:
    Oct 21, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 21, 2022