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

Osteoarthritis, Knee Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765189
• Other study ID #: MNGEFS
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 26, 2023

Study information

• Verified date: December 2023
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Placebo
Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.
• Verum A
Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.
• Verum B
Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.
• Verum C
Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.

Locations

Country	Name	City	State
Spain	UCAM (Universidad Catolica San Antonio de Murcia)	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire		12 weeks
Primary	Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm		12 weeks
Secondary	Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire		12 weeks
Secondary	Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire		12 weeks
Secondary	Change in knee mobility assessed with ROM (Range of Motion) assessment		12 weeks
Secondary	Change in muscular strength assessed with isokinetic strength measurment		12 weeks
Secondary	Change in inflammatory status assessed with TNF-alpha plasma concentration		12 weeks
Secondary	Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration		12 weeks
Secondary	Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration		12 weeks
Secondary	Change in inflammatory status assessed with IL-1beta plasma concentration		12 weeks
Secondary	Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration		12 weeks
Secondary	Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration		12 weeks
Secondary	Change in quality of life assessed with SF-12 questionnaire		12 weeks
Secondary	Change in pain killer drug consumption assessed with daily diary		12 weeks