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NCT Number: NCT04765189

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Verum A

Dietary Supplement

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

Verum B

Dietary Supplement

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

Verum C

Dietary Supplement

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

Primary outcomes

  1. Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire

    Time frame: 12 weeks

  2. Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm

    Time frame: 12 weeks

Secondary outcomes

  1. Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire

    Time frame: 12 weeks

  2. Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire

    Time frame: 12 weeks

  3. Change in knee mobility assessed with ROM (Range of Motion) assessment

    Time frame: 12 weeks

  4. Change in muscular strength assessed with isokinetic strength measurment

    Time frame: 12 weeks

  5. Change in inflammatory status assessed with TNF-alpha plasma concentration

    Time frame: 12 weeks

  6. Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration

    Time frame: 12 weeks

  7. Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration

    Time frame: 12 weeks

  8. Change in inflammatory status assessed with IL-1beta plasma concentration

    Time frame: 12 weeks

  9. Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration

    Time frame: 12 weeks

  10. Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration

    Time frame: 12 weeks

  11. Change in quality of life assessed with SF-12 questionnaire

    Time frame: 12 weeks

  12. Change in pain killer drug consumption assessed with daily diary

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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