Nutritional Supplements for Exercise Recovery
Evaluation of Nutritional Supplements for Exercise Recovery
1 other identifier
interventional
10
1 country
1
Brief Summary
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2018
CompletedStudy Start
First participant enrolled
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 27, 2019
February 1, 2019
3 months
March 14, 2018
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
post-exercise muscle soreness
VAS score
7 days
Secondary Outcomes (4)
post-exercise muscle strength
7 days
post-exercise muscle function
7 days
satiety
4-5 hours
sleep quality
15 days
Study Arms (2)
Placebo
PLACEBO COMPARATORtaste, color, and calorie-matched to supplement
Supplement
EXPERIMENTALProprietary protein and fruit extract blend
Interventions
dietary supplement contain protein from milk and fruit extract
Eligibility Criteria
You may qualify if:
- Ability to consume supplement
- Willing to adhere to the study intervention regimen
- Willing to abstain from analgesics for duration of the study
- Agreement to adhere to Lifestyle Considerations
You may not qualify if:
- Current use of NSAIDs
- Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes
- Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions
- Weight \> 350 pounds
- Pregnancy or lactation
- Known food allergies or sensitivities or dietary restrictions
- Habitual consumption of \> 2 alcoholic drinks per day
- Febrile illness or antibiotic use within 1 month prior to baseline testing
- Treatment with another investigational drug or other intervention within 1 month
- Current smoker or tobacco use within 1 month
- Any condition(s) or diagnosis, both physical or psychological, that, in the opinion of the principal investigator or study physician, precludes participation and/or ability to consent
- Any other factor that, in the opinion of the principal investigator or study physician, would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catherine Mikuslead
Study Sites (1)
Beachbody
El Segundo, California, 90245, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine R Mikus, PhD
Beachbody, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
March 14, 2018
First Posted
April 27, 2018
Study Start
March 20, 2018
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 27, 2019
Record last verified: 2019-02