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