Osteoarthritis, KneeNCT04765189
Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II
A study testing Verum A, Verum B and Verum C in people with Osteoarthritis, Knee, run by Fytexia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Verum A, Verum B and Verum C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Placebo, Verum A, Verum B, Verum C
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.
Verum ADietary supplement
Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.
Verum BDietary supplement
Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.
Verum CDietary supplement
Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Verum A | Experimental | Not described Receives: Dietary Supplement: Verum A |
| Verum B | Experimental | Not described Receives: Dietary Supplement: Verum B |
| Verum C | Experimental | Not described Receives: Dietary Supplement: Verum C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Measured: 12 weeks
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
Measured: 12 weeks
Secondary outcomes (12)
Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Measured: 12 weeks
Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Measured: 12 weeks
Change in knee mobility assessed with ROM (Range of Motion) assessment
Measured: 12 weeks
Change in muscular strength assessed with isokinetic strength measurment
Measured: 12 weeks
Change in inflammatory status assessed with TNF-alpha plasma concentration
Measured: 12 weeks
Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
Measured: 12 weeks
Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
Measured: 12 weeks
Change in inflammatory status assessed with IL-1beta plasma concentration
Measured: 12 weeks
Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
Measured: 12 weeks
Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
Measured: 12 weeks
Change in quality of life assessed with SF-12 questionnaire
Measured: 12 weeks
Change in pain killer drug consumption assessed with daily diary
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz, Principal investigator, UCAM (Universidad Catolica San Antonio de Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765189
- Sponsor's protocol ID
- MNGEFS
- Status last verified
- Dec 2023
- First submitted
- 19 Feb 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04765189
- Acronym / sponsor ID
- MNGEFS
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules. | Dietary supplement | Placebo |
| Verum AVerum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules. | Dietary supplement | Verum A |
| Verum BVerum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules. | Dietary supplement | Verum B |
| Verum CVerum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules. | Dietary supplement | Verum C |
Primary outcome
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time frame: 12 weeks
Change in knee joint subjective pain rating using a VAS (Visual Analog Scale) 0-10 cm
Time frame: 12 weeks
12 secondary outcomes
Change in knee joint stifness subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time frame: 12 weeks
Change in knee joint physical functionning subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire
Time frame: 12 weeks
Change in knee mobility assessed with ROM (Range of Motion) assessment
Time frame: 12 weeks
Change in muscular strength assessed with isokinetic strength measurment
Time frame: 12 weeks
Change in inflammatory status assessed with TNF-alpha plasma concentration
Time frame: 12 weeks
Change in inflammatory status assessed with TNF-alpha receptor R1 plasma concentration
Time frame: 12 weeks
Change in inflammatory status assessed with TNF-alpha receptor R2 plasma concentration
Time frame: 12 weeks
Change in inflammatory status assessed with IL-1beta plasma concentration
Time frame: 12 weeks
Change in inflammatory status assessed with IL-1beta receptor p68 plasma concentration
Time frame: 12 weeks
Change in inflammatory status assessed with IL-1beta receptor p80 plasma concentration
Time frame: 12 weeks
Change in quality of life assessed with SF-12 questionnaire
Time frame: 12 weeks
Change in pain killer drug consumption assessed with daily diary
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Alcaraz principal investigator
UCAM (Universidad Catolica San Antonio de Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum A, Verum B and Verum C in people with Osteoarthritis, Knee, run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee joint pain subscale from WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.