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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Dietary Supplement: Verum B; Dietary Supplement: Verum A; Dietary Supplement: Verum C; Dietary Supplement: Placebo

• Registration Number: NCT04765189
• Lead Sponsor: Fytexia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-03-01
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum B	Verum B	-
Verum A	Verum A	-
Verum C	Verum C	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCAM (Universidad Catolica San Antonio de Murcia); 🇪🇸 Murcia, Spain