NCT02589249

The Effect of AyuFlex® Supplementation on Joint Health

The Effect of AyuFlex® Dietary Supplementation on Joint Mobility, Comfort and Functional Capacity in Healthy Overweight Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: The Center for Applied Health Sciences, LLC · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this 12-week, prospective study is to determine the effects of oral supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility, joint comfort and functional capacity in healthy overweight subjects.

Detailed description

This interventional study is a 12-week, randomized, double-blind, placebo and dose-response controlled clinical trial (in 3 parallel groups) of male and female subjects without active osteoarthritis of the knee to be recruited at a single investigational center in the U.S. A two-week placebo lead-in period will precede the study to enhance statistical power. One-hundred and five (105) overweight, apparently healthy subjects, pre-screened using health history questionnaires, vital signs, blood work and a standardized lower extremity exercise performance test will be randomized to one of three groups for 84 days: placebo, AyuFlex1 (500 mg/d) or AyuFlex2 (1000 mg/d). AyuFlex is an organic, non-GMO, over-the-counter joint health product derived from the edible fruits of Terminalia chebula.

Conditions

• Arthralgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AyuFlex	Active product
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-02-07
• Completion: 2017-02-07
• First posted: 2015-10-28
• Last updated: 2017-04-18