- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510806
Nutritional Supplements for Exercise Recovery
February 25, 2019 updated by: Catherine Mikus
Evaluation of Nutritional Supplements for Exercise Recovery
This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
El Segundo, California, United States, 90245
- Beachbody
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
taste, color, and calorie-matched to supplement
|
color, taste, and calorie-matched placebo
|
Experimental: Supplement
Proprietary protein and fruit extract blend
|
dietary supplement contain protein from milk and fruit extract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-exercise muscle soreness
Time Frame: 7 days
|
VAS score
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-exercise muscle strength
Time Frame: 7 days
|
countermovement jump performance
|
7 days
|
post-exercise muscle function
Time Frame: 7 days
|
repetitive countermovement jumps
|
7 days
|
satiety
Time Frame: 4-5 hours
|
VAS scores
|
4-5 hours
|
sleep quality
Time Frame: 15 days
|
sleep metrics, Fitbit
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine R Mikus, PhD, Beachbody, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2018
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
April 17, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03132018BB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-exercise Muscle Soreness
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Prof. Dr. med. Frank Christoph MoorenUniversity of Giessen; Biologische Heilmittel Heel GmbHCompletedExercise-induced Muscle SorenessGermany
-
Prof. Dr. med. Frank Christoph MoorenUniversity of Giessen; Biologische Heilmittel Heel GmbHCompletedExercise-induced Muscle SorenessGermany
-
University of VermontCompletedExercise-induced Delayed Onset Muscle SorenessUnited States
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Northumbria UniversityNewcastle University; Maastricht University; Sugar NutritionCompletedLiver and Muscle Glycogen Replenishment Post-exerciseUnited Kingdom
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Mucos Pharma GmbH & Co. KGCompletedMuscle Soreness | Muscle Injury | Exercise Induced Muscle DamageGermany
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University College CorkSouth East Technological UniversityCompletedStress | Anxiety | Muscle Soreness | Muscle Damage | Exercise Performance | Gut MicrobiomeIreland
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Kaohsiung Medical University Chung-Ho Memorial...CompletedDelayed-onset Muscle SorenessTaiwan
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