Trials / Completed
CompletedNCT04765189
Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Fytexia · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Placebo | Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules. |
| DIETARY_SUPPLEMENT | Verum A | Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules. |
| DIETARY_SUPPLEMENT | Verum B | Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules. |
| DIETARY_SUPPLEMENT | Verum C | Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-10-26
- Completion
- 2023-10-26
- First posted
- 2021-02-21
- Last updated
- 2023-12-05
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04765189. Inclusion in this directory is not an endorsement.