NCT04765189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

February 19, 2021

Last Update Submit

December 4, 2023

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Verum A

EXPERIMENTAL
Dietary Supplement: Verum A

Verum B

EXPERIMENTAL
Dietary Supplement: Verum B

Verum C

EXPERIMENTAL
Dietary Supplement: Verum C

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo
Verum ADIETARY_SUPPLEMENT

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

Verum A
Verum BDIETARY_SUPPLEMENT

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

Verum B
Verum CDIETARY_SUPPLEMENT

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

Verum C

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pedro Alcaraz

    UCAM (Universidad Catolica San Antonio de Murcia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 21, 2021

Study Start

March 1, 2021

Primary Completion

October 26, 2023

Study Completion

October 26, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

ES(1)