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

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

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.

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