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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

NCT ID: NCT04765189

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-10-26

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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.

Verum A

Group Type EXPERIMENTAL

Verum A

Intervention Type DIETARY_SUPPLEMENT

Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.

Verum B

Group Type EXPERIMENTAL

Verum B

Intervention Type DIETARY_SUPPLEMENT

Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.

Verum C

Group Type EXPERIMENTAL

Verum C

Intervention Type DIETARY_SUPPLEMENT

Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.

Interventions

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Placebo

Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.

Intervention Type DIETARY_SUPPLEMENT

Verum A

Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.

Intervention Type DIETARY_SUPPLEMENT

Verum B

Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.

Intervention Type DIETARY_SUPPLEMENT

Verum C

Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fytexia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Alcaraz

Role: PRINCIPAL_INVESTIGATOR

UCAM (Universidad Catolica San Antonio de Murcia)

Locations

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UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MNGEFS

Identifier Type: -

Identifier Source: org_study_id