Whey Protein Supplementation in High School Athletes

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05589129
• Other study ID #: 00145632
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: October 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: May 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Performance
• Body Weight
• Body Weight Changes
• Recovery
• Sleep

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Grace Zimmerman	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in adiponectin	Measured via blood sample to assess levels of fatty acid oxidation as well as inflammation	Measured at baseline and post-intervention (10-12-weeks)
Other	Changes in interleukin-6	Measured via blood sample to assess inflammation	Measured at baseline and post-intervention (10-12-weeks)
Other	Changes in fibroblast growth factor 21	Measured via blood sample to assess muscle hypertrophy	Measured at baseline and post-intervention (10-12-weeks)
Other	Changes in follistatin	Measured via blood sample to assess muscle hypertrophy	Measured at baseline and post-intervention (10-12-weeks)
Other	Changes in delayed onset muscle soreness	Measured via likert scale questionnaire	Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Other	Changes in Sleep quality	Measured via Pittsburgh Sleep Quality Index questionnaire	Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Other	Changes in dietary habits	Measured via a 3-day food recall	Measured at baseline, 5-weeks and post-intervention (10-12-weeks)
Other	Sleep Chronotype	Measured by the Munich Chronotype Questionnaire to evaluate the morningness-eveningness of participants.	Measured at baseline.
Primary	Changes in Fat Free Mass	Measured via BodPod	Measured at baseline and post-intervention (10-12-weeks)
Primary	Changes in Fat Mass	Measured via BodPod	Measured at baseline and post-intervention (10-12-weeks)
Secondary	Estimated Cardiorespiratory Fitness (V02max)	Measured via 1.5-mile run time	Measured at baseline and post-intervention (10-12-weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Changes in Speed	30 yard sprint	Measured at baseline and post-intervention (10-12-weeks)
Secondary	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)