Nutritional Supplements for Exercise Recovery
Primary Purpose
Post-exercise Muscle Soreness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplement
Placebo
Sponsored by
About this trial
This is an interventional other trial for Post-exercise Muscle Soreness
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beachbody
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Supplement
Arm Description
taste, color, and calorie-matched to supplement
Proprietary protein and fruit extract blend
Outcomes
Primary Outcome Measures
post-exercise muscle soreness
VAS score
Secondary Outcome Measures
post-exercise muscle strength
countermovement jump performance
post-exercise muscle function
repetitive countermovement jumps
satiety
VAS scores
sleep quality
sleep metrics, Fitbit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03510806
Brief Title
Nutritional Supplements for Exercise Recovery
Official Title
Evaluation of Nutritional Supplements for Exercise Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Mikus
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
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-exercise Muscle Soreness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
taste, color, and calorie-matched to supplement
Arm Title
Supplement
Arm Type
Experimental
Arm Description
Proprietary protein and fruit extract blend
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement
Intervention Description
dietary supplement contain protein from milk and fruit extract
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
color, taste, and calorie-matched placebo
Primary Outcome Measure Information:
Title
post-exercise muscle soreness
Description
VAS score
Time Frame
7 days
Secondary Outcome Measure Information:
Title
post-exercise muscle strength
Description
countermovement jump performance
Time Frame
7 days
Title
post-exercise muscle function
Description
repetitive countermovement jumps
Time Frame
7 days
Title
satiety
Description
VAS scores
Time Frame
4-5 hours
Title
sleep quality
Description
sleep metrics, Fitbit
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine R Mikus, PhD
Organizational Affiliation
Beachbody, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beachbody
City
El Segundo
State/Province
California
ZIP/Postal Code
90245
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Nutritional Supplements for Exercise Recovery
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