Whey Protein Supplementation in High School Athletes
Primary Purpose
Body Weight Changes, Athletic Performance, Recovery
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey Protein Supplement
Carbohydrate Placebo Control
Sponsored by
About this trial
This is an interventional other trial for Body Weight Changes
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.
Sites / Locations
- Grace Zimmerman
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Whey Protein Supplement
Carbohydrate Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in Fat Free Mass
Measured via BodPod
Changes in Fat Mass
Measured via BodPod
Secondary Outcome Measures
Estimated Cardiorespiratory Fitness (V02max)
Measured via 1.5-mile run time
Changes in Muscular Fatigue
Measured via leg extension machine (HumacNorm) using isometric muscle contraction in the quadriceps muscle.
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.
Sleep Duration
Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep.
Changes in Speed
30 yard sprint
Sleep Staging
Measured via Fitbit devices. Sleep stages are different periods of sleep where muscle tone and heart rate vary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05589129
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Athletic Performance, Recovery, Sleep
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whey Protein Supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Carbohydrate Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein Supplement
Other Intervention Name(s)
Optimum Nutrition Gold Standard 100% Whey
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate Placebo Control
Other Intervention Name(s)
Nesquik Chocolate Powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Fat Free Mass
Description
Measured via BodPod
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Changes in Fat Mass
Description
Measured via BodPod
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Secondary Outcome Measure Information:
Title
Estimated Cardiorespiratory Fitness (V02max)
Description
Measured via 1.5-mile run time
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Changes in Muscular Fatigue
Description
Measured via leg extension machine (HumacNorm) using isometric muscle contraction in the quadriceps muscle.
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Sleep Efficiency
Description
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, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Title
Sleep Duration
Description
Measured via Fitbit devices. Sleep duration is measured based on how long the individual is asleep.
Time Frame
Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Title
Changes in Speed
Description
30 yard sprint
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Sleep Staging
Description
Measured via Fitbit devices. Sleep stages are different periods of sleep where muscle tone and heart rate vary.
Time Frame
Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Other Pre-specified Outcome Measures:
Title
Changes in adiponectin
Description
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)
Title
Changes in interleukin-6
Description
Measured via blood sample to assess inflammation
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Changes in fibroblast growth factor 21
Description
Measured via blood sample to assess muscle hypertrophy
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Changes in follistatin
Description
Measured via blood sample to assess muscle hypertrophy
Time Frame
Measured at baseline and post-intervention (10-12-weeks)
Title
Changes in delayed onset muscle soreness
Description
Measured via likert scale questionnaire
Time Frame
Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Title
Changes in Sleep quality
Description
Measured via Pittsburgh Sleep Quality Index questionnaire
Time Frame
Measured at baseline, 2-, 4-, 6-, 8-weeks and post-intervention (10-12-weeks)
Title
Changes in dietary habits
Description
Measured via a 3-day food recall
Time Frame
Measured at baseline, 5-weeks and post-intervention (10-12-weeks)
Title
Sleep Chronotype
Description
Measured by the Munich Chronotype Questionnaire to evaluate the morningness-eveningness of participants.
Time Frame
Measured at baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Grace Zimmerman
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Request for deidentified data can be made to the PI on a case-by-case basis.
Learn more about this trial
Whey Protein Supplementation in High School Athletes
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