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

Fytexia95 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 in the past 10 years * 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

Outcomes

Primary Outcomes

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 Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes