Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2022-07-14
2022-10-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 Control
Carbohydrate control will come in powder form and will consist of 20g of carbohydrate and 21.6g of product. We will use Nesquik Chocolate Powder mix.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
13 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tanya Halliday
Principal Investigator, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tanya Halliday, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grace Zimmerman
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00145632
Identifier Type: -
Identifier Source: org_study_id