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

NCT04765189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-12-05

No results posted yet for this study

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

  • Osteoarthritis, Knee

Interventions

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.

Sponsors & Collaborators

  • Fytexia

    lead INDUSTRY

Principal Investigators

  • Pedro Alcaraz · UCAM (Universidad Catolica San Antonio de Murcia)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-10-26
Completion
2023-10-26

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765189 on ClinicalTrials.gov