Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II

Overview

The aim of the present investigation is to evaluate the efficacy of Mangoselect®, a mangosteen extract, and of a formulation containing Mangoselect®, in subjects suffering from activity/exercise-induced knee joint pain/discomfort, during a 12-week supplementation period. Subjective discomfort improvement will be assessed with both WOMAC questionnaire and pain Visual Analogic Scale (VAS); functional joints features, quality of life, and inflammatory markers, will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after the end of the supplementation period. The design of the study is double-blind, randomized, multi-arm, parallel and placebo controlled.

Full Title of Study: “Evaluation of the Efficacy of Mangoselect®, a Mangosteen Extract, and of a Formulation Containing Mangoselect®, in Subjects Suffering From Activity/Exercise-induced Knee Joint Discomfort During a 12-week Supplementation Period. A Double-blind, Randomized, Multi-arm, Parallel and Placebo-controlled Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Interventions

  • Dietary Supplement: Placebo
    • Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.
  • Dietary Supplement: Verum A
    • Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.
  • Dietary Supplement: Verum B
    • Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.
  • Dietary Supplement: Verum C
    • Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Verum A
  • Experimental: Verum B
  • Experimental: Verum C

Clinical Trial Outcome Measures

Primary Measures

  • Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
    • Time Frame: 12 weeks
  • Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
    • Time Frame: 12 weeks

Secondary Measures

  • Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
    • Time Frame: 12 weeks
  • Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
    • Time Frame: 12 weeks
  • Change in knee mobility assessed with ROM (Range of Motion) assessment
    • Time Frame: 12 weeks
  • Change in muscular strength assessed with isokinetic strength measurment
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with TNF-alpha plasma concentration
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with IL-1beta plasma concentration
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
    • Time Frame: 12 weeks
  • Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
    • Time Frame: 12 weeks
  • Change in quality of life assessed with SF-12 questionnaire
    • Time Frame: 12 weeks
  • Change in pain killer drug consumption assessed with daily diary
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Physically active volunteers – BMI 22-29.9 kg/m2 – Declaring knee joint pain during and/or after activity/exercise – Joint knee pain rated of at least 4 cm on a 10 cm VAS following activity/exercise – Diagnosed osteoarthritis grade I or II according to Kellgren-Lawrence classification Exclusion Criteria:

  • Diagnosed inflammatory joint disorder or osteoarthritis grade III or more according to Kellgren-Lawrence classification – Currentlu chronically taking pain killer drugs or dietary supplement or intra-articular treatment 3 months before selection – Anemia – Subjects with knee/joint surgery/replacement – Significant injury of the studied knee joint 12 months before selection – Unable to carry out functional tests and/or questionnaires – Currently participating or having participated in another clinical trial in the 3 previous months – Pregnant women and women positive at Beta-HCG serology test – Any condition that the investigator believes would interfere with the ability to provide inform consent, or comply with study instructions, or confound the interpretations of the study results, or put the volunteer at undue risk – Allergy to one of the component of the supplements

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fytexia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pedro Alcaraz, Principal Investigator, UCAM (Universidad Catolica San Antonio de Murcia)
  • Overall Contact(s)
    • Julien Cases, (+33) 467 219 098, jcases@fytexia.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.