Clinical trial NCT05589129: Whey Protein Supplementation in High School Athletes
Official title: Effects of a Whey Protein Supplement on Performance, Recovery, and Body Composition in Adolescent Soccer Players During the Competitive Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Athletic Performance
Recovery
Sleep
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Fat Free Mass
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in Fat Mass
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
Secondary outcomes:
measure: Estimated Cardiorespiratory Fitness (V02max)
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in Muscular Fatigue
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Sleep Efficiency
timeFrame: Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
measure: Sleep Duration
timeFrame: Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
measure: Changes in Speed
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Sleep Staging
timeFrame: Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Other outcomes:
measure: Changes in adiponectin
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in interleukin-6
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in fibroblast growth factor 21
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in follistatin
timeFrame: Measured at baseline and post-intervention (10-12-weeks)
measure: Changes in delayed onset muscle soreness
timeFrame: Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
measure: Changes in Sleep quality
timeFrame: Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
measure: Changes in dietary habits
timeFrame: Measured at baseline, 5-weeks and post-intervention (10-12-weeks)
measure: Sleep Chronotype
timeFrame: Measured at baseline.
Locations:
city: Salt Lake City
country: United States
facility: Grace Zimmerman
state: Utah
Study officials:
affiliation: University of Utah
name: Tanya Halliday, PhD
role: PRINCIPAL_INVESTIGATOR
References: