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.

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Verum A; Dietary supplement: Verum B; Dietary supplement: Verum C

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • UCAM (Universidad Catolica San Antonio de Murcia)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fytexia
• Investigators: Principal Investigator: Pedro Alcaraz, UCAM (Universidad Catolica San Antonio de Murcia)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MNGEFS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No