Clinical trial NCT04765189: Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
timeFrame: 12 weeks
measure: Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
timeFrame: 12 weeks
measure: Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
timeFrame: 12 weeks
measure: Change in knee mobility assessed with ROM (Range of Motion) assessment
timeFrame: 12 weeks
measure: Change in muscular strength assessed with isokinetic strength measurment
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with TNF-alpha plasma concentration
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with IL-1beta plasma concentration
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
timeFrame: 12 weeks
measure: Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
timeFrame: 12 weeks
measure: Change in quality of life assessed with SF-12 questionnaire
timeFrame: 12 weeks
measure: Change in pain killer drug consumption assessed with daily diary
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (Universidad Catolica San Antonio de Murcia)
Study officials:
affiliation: UCAM (Universidad Catolica San Antonio de Murcia)
name: Pedro Alcaraz
role: PRINCIPAL_INVESTIGATOR
References: