Clinical Trial: The Effect of AyuFlex® Supplementation on Joint Health
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of AyuFlex® Dietary Supplementation on Joint Mobility, Comfort and Functional Capacity in Healthy Overweight Subjects
Brief 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 Summary: 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.
Sponsor: The Center for Applied Health Sciences, LLC
Current Primary Outcome:
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]
- Visual Analogue Scale scores for discomfort, mobility, disability [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Inflammatory biomarkers [ Time Frame: Change from Day 0 to 84 ]tumor necrosis factor-alpha, c-reactive protein, and cartilage oligomeric matrix protein
- 6 minute walk test [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]Total distance covered in 6 minutes
- Range of motion of pain-free knee flexion/extension [ Time Frame: Change from Day 0 to 84 ]
- Blood chemistry [ Time Frame: Change from Day 0 to 84 ]Comprehensive metabolic panel, CBC, lipid panel
- Vital signs [ Time Frame: Change in score from Day 0 to day 14, 42, and 84 ]Resting heart rate and blood pressure
Original Secondary Outcome: Same as current
Information By: The Center for Applied Health Sciences, LLC
Dates:
Date Received: October 26, 2015
Date Started: November 2015
Date Completion:
Last Updated: April 16, 2017
Last Verified: April 2017