Grace Zimmerman
Salt Lake City, Utah, 84112, United States
NCT Number: NCT05589129
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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Notify Me13 year–18 year
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84112, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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).
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Measured using a 30 yard sprint
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.
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)
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)
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.
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.
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
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Measured via blood sample
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Measured via blood sample to assess muscle hypertrophy
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.
Time frame: Measured at baseline and post-intervention (10-12-weeks)
Measured via a 3-day food recall
University of Utah
Other
Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season
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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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