Nutritional Supplements for Exercise Recovery

Post-exercise Muscle Soreness Clinical Trial

Official title:

Evaluation of Nutritional Supplements for Exercise Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510806
• Other study ID #: 03132018BB
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2019
• Source: Beachbody
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Myalgia
• Post-exercise Muscle Soreness

Intervention

Dietary Supplement:
• Supplement
dietary supplement contain protein from milk and fruit extract

Other:
• Placebo
color, taste, and calorie-matched placebo

Locations

Country	Name	City	State
United States	Beachbody	El Segundo	California

Sponsors (1)

Lead Sponsor	Collaborator
Catherine Mikus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-exercise muscle soreness	VAS score	7 days
Secondary	post-exercise muscle strength	countermovement jump performance	7 days
Secondary	post-exercise muscle function	repetitive countermovement jumps	7 days
Secondary	satiety	VAS scores	4-5 hours
Secondary	sleep quality	sleep metrics, Fitbit	15 days