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

Fytexia

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Dietary Supplement: Verum B; Dietary Supplement: Verum A; Dietary Supplement: Placebo; Dietary Supplement: Verum C

Study type: Interventional

Funder types: Industry

Identifiers

NCT04765189

MNGEFS

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Verum A

Experimental group

Treatment:

Dietary Supplement: Verum A

Verum B

Experimental group

Treatment:

Dietary Supplement: Verum B

Verum C

Experimental group

Treatment:

Dietary Supplement: Verum C