search
Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Verum A
Verum B
Verum C
Sponsored by
Fytexia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCAM (Universidad Catolica San Antonio de Murcia)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Verum A

Verum B

Verum C

Arm Description

Outcomes

Primary Outcome Measures

Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm

Secondary Outcome Measures

Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Change in knee mobility assessed with ROM (Range of Motion) assessment
Change in muscular strength assessed with isokinetic strength measurment
Change in inflammatory status assessed with TNF-alpha plasma concentration
Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
Change in inflammatory status assessed with IL-1beta plasma concentration
Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
Change in quality of life assessed with SF-12 questionnaire
Change in pain killer drug consumption assessed with daily diary

Full Information

First Posted
February 19, 2021
Last Updated
September 11, 2023
Sponsor
Fytexia
search

1. Study Identification

Unique Protocol Identification Number
NCT04765189
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Verum A
Arm Type
Experimental
Arm Title
Verum B
Arm Type
Experimental
Arm Title
Verum C
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum A
Intervention Description
Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum B
Intervention Description
Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum C
Intervention Description
Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.
Primary Outcome Measure Information:
Title
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time Frame
12 weeks
Title
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time Frame
12 weeks
Title
Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time Frame
12 weeks
Title
Change in knee mobility assessed with ROM (Range of Motion) assessment
Time Frame
12 weeks
Title
Change in muscular strength assessed with isokinetic strength measurment
Time Frame
12 weeks
Title
Change in inflammatory status assessed with TNF-alpha plasma concentration
Time Frame
12 weeks
Title
Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
Time Frame
12 weeks
Title
Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
Time Frame
12 weeks
Title
Change in inflammatory status assessed with IL-1beta plasma concentration
Time Frame
12 weeks
Title
Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
Time Frame
12 weeks
Title
Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
Time Frame
12 weeks
Title
Change in quality of life assessed with SF-12 questionnaire
Time Frame
12 weeks
Title
Change in pain killer drug consumption assessed with daily diary
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Cases
Phone
(+33) 467 219 098
Email
jcases@fytexia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Alcaraz
Organizational Affiliation
UCAM (Universidad Catolica San Antonio de Murcia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM (Universidad Catolica San Antonio de Murcia)
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda H Chung
Phone
(+34) 968 278 611
Email
lhchung@ucam.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs