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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Verum A | Experimental |
| |
| Verum B | Experimental |
| |
| Verum C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Alcaraz | UCAM (Universidad Catolica San Antonio de Murcia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM (Universidad Catolica San Antonio de Murcia) | Murcia | Spain |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Verum A | Dietary Supplement | Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules. |
|
| Verum B | Dietary Supplement | Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules. |
|
| Verum C | Dietary Supplement | Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules. |
|
| 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 |
| D012216 |
| Rheumatic Diseases |