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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Verum A
* Dietary Supplement: Verum B
* Dietary Supplement: Verum C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.<br>|
| Experimental: Verum A<br> | Dietary Supplement: Verum A<br>* Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.<br>|
| Experimental: Verum B<br> | Dietary Supplement: Verum B<br>* Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.<br>|
| Experimental: Verum C<br> | Dietary Supplement: Verum C<br>* Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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