Joint PainsECUM-RUNNCT07699575
Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial
A study testing 9-5-1 in people with Joint Pains, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
ECUM-RUN is a randomized, double-blind, placebo-controlled phase 3 trial evaluating whether a 30-day oral supplementation with curcumin, ginger, and piperine (9-5-1 formulation) reduces exercise-induced joint pain and inflammatory markers in 82 ultra-trail runners competing in the Diagonale des Fous (175 km). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint Pains
- What is being tested?
- 9-5-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at inclusion
- Registered for "La Diagonale des Fous" (Grand Raid de La Réunion, 175 km, 2026 edition)
- Free, informed, signed consent obtained prior to any study-related procedure
- Availability to participate in the full protocol, including preliminary consultations and biological sampling at all time points (T0 to T3)
- Affiliated with or beneficiary of a social security scheme
- Ability to understand and follow study instructions (sufficient French language level, or assistance available)
Who cannot join
- Regular NSAID use in the 30 days prior to inclusion, defined as intake at least 3 days/week for at least 2 consecutive weeks, or ongoing treatment at the time of inclusion
- Regular use of curcumin-containing supplements or "9-5-1"-type preparations in the 30 days prior to inclusion, defined as intake at least 3 days/week for at least 2 consecutive weeks
- Taking anticoagulant treatment
- History of hepatic, biliary, or pancreatic disease, including: gallstones, cholestasis, acute or chronic hepatitis, cirrhosis
- Known allergy or documented hypersensitivity to any capsule component: turmeric, curcumin, ginger, black pepper, maltodextrin, or hydroxypropylmethylcellulose (HPMC)
- Chronic inflammatory joint disease (e.g., rheumatoid arthritis, spondyloarthritis) under active specific treatment
Show all 10Show fewer
- Pregnancy or breastfeeding
- Participation in another biomedical study involving a therapeutic intervention within the 30 days prior to inclusion
- Severe cognitive or psychiatric impairment preventing understanding of the protocol or completion of questionnaires
- Patient under guardianship/curatorship or subject to a legal protection order
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Dr Nicolas BOUSCAREN
Saint-Pierre, CHU de La Réunion, 97400
PINARD, 0262353530
Céleste
About this study
ECUM-RUN is a randomized, double-blind, placebo-controlled phase 3 trial evaluating whether a 30-day oral supplementation with curcumin, ginger, and piperine (9-5-1 formulation) reduces exercise-induced joint pain and inflammatory markers in 82 ultra-trail runners competing in the Diagonale des Fous (175 km). The primary endpoint is the change in knee pain (VAS score) between end of supplementation and race finish, compared between intervention and placebo groups.
- Conditions
- Joint Pains
- Being tested
- 9-5-1, Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-5-1Dietary supplement
The investigational intervention is an oral food-supplement capsule combining curcumin, ginger, and piperine in a proprietary "9-5-1" ratio (curcuma extract : ginger extract : black pepper/piperine extract), administered as 4 capsules per day for 30 consecutive days prior to the race.
PlaceboDietary supplement
Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
| Study group | Role | What they receive |
|---|---|---|
| 9-5-1 | Experimental | Not described Receives: Dietary Supplement: 9-5-1 |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Knee pain is self-assessed using a Visual Analog Scale (VAS, 0-10 cm) at the end of the 30-day supplementation period (T1, day before the race) and immediately at race finish or withdrawal (T2). The primary outcome is the within-participant change in VAS score (T2 minus T1), compared between the curcumin-ginger-piperine (9-5-1) group and the placebo group.
Measured: From Day 30 (T1, end of the 30-day supplementation period) to race finish or withdrawal (T2) - up to approximately 60 hours later, corresponding to the maximum allowed race duration.
Secondary outcomes (11)
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Pain intensity at the ankles, knees, and hips is self-assessed using a Visual Analog Scale (VAS, 0-10 cm) at each of the four measurement time points. Between-group differences (intervention vs. placebo) in the T2-T1 change are compared, and a mixed linear model is used to describe the overall pain trajectory from T0 to T3, accounting for repeated within-participant measures.
Measured: (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in Joint Range of Motion (Ankles, Knees, Hips)
Range of motion for each joint movement (in degrees) is measured by goniometry, separately for each joint and side, at each of the four time points. Between-group differences in the T2-T1 change in range of motion are compared for each joint tested.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)
Venous blood samples are collected at each study visit to measure serum IL-1β, IL-6, IL-8, IL-1ra and IL-10 and TNF-α concentrations. Between-group differences in the T2-T1 change are compared for each cytokine, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in Inflammatory biomarkers (ng/mL)
Venous blood samples are collected to measure serum calprotectin, resistin, and leptin concentrations. Between-group differences in the T2-T1 change are compared for each biomarker, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in serum enzyme activity (U/L)
Venous blood samples are collected to measure serum creatine kinase (CK), alanine aminotransferase (ALT), and aspartate aminotransferase (AST). Between-group differences in the T2-T1 change are compared for each enzyme, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Oxidative stress and adiponectin (µmol/L)
Venous blood samples are collected to measure serum malondialdehyde (MDA) and adiponectin. Between-group differences in the T2-T1 change are compared for each enzyme, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Changein serum creatinine (µmol/L)
Venous blood samples are collected to measure serum creatinine. Between-group differences in the T2-T1 change are compared for each enzyme, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in blood urea (mmol/L)
Venous blood samples are collected to measure in blood urea. Between-group differences in the T2-T1 change are compared for each enzyme, and mixed linear models describe their kinetics across T0-T3.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in coagulation parameters
Venous blood samples are collected to assess prothrombin time (PT, %) and international normalized ratio (INR). Between-group differences in the T2-T1 change are compared for each parameter, and mixed linear models describe their kinetics across T0-T3
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Clinical tolerance
Clinical tolerance is assessed at each study visit by recording digestive symptoms, allergic reactions, and other adverse events.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Biological safety laboratory parameters
Biological safety is assessed using routine laboratory parameters evaluating liver function, renal function, and coagulation throughout the study.
Measured: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start14 Sep 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699575
- Sponsor's protocol ID
- 2025/RUN/0056
- Other IDs
- 2026-A00478-43
- Acronym
- ECUM-RUN
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07699575
- Acronym / sponsor ID
- ECUM-RUN / 2025/RUN/0056
- Conditions
- Joint Pains
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 13 Jul 2026 (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.
ECUM-RUN is a randomized, double-blind, placebo-controlled phase 3 trial evaluating whether a 30-day oral supplementation with curcumin, ginger, and piperine (9-5-1 formulation) reduces exercise-induced joint pain and inflammatory markers in 82 ultra-trail runners competing in the Diagonale des Fous (175 km). The primary endpoint is the change in knee pain (VAS score) between end of supplementation and race finish, compared between intervention and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9-5-1 | Experimental | Dietary Supplement: 9-5-1 |
| Control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years at inclusion
- Registered for "La Diagonale des Fous" (Grand Raid de La Réunion, 175 km, 2026 edition)
- Free, informed, signed consent obtained prior to any study-related procedure
- Availability to participate in the full protocol, including preliminary consultations and biological sampling at all time points (T0 to T3)
- Affiliated with or beneficiary of a social security scheme
Key exclusion criteria (10 listed)
- Regular NSAID use in the 30 days prior to inclusion, defined as intake at least 3 days/week for at least 2 consecutive weeks, or ongoing treatment at the time of inclusion
- Regular use of curcumin-containing supplements or "9-5-1"-type preparations in the 30 days prior to inclusion, defined as intake at least 3 days/week for at least 2 consecutive weeks
- Taking anticoagulant treatment
- History of hepatic, biliary, or pancreatic disease, including: gallstones, cholestasis, acute or chronic hepatitis, cirrhosis
- Known allergy or documented hypersensitivity to any capsule component: turmeric, curcumin, ginger, black pepper, maltodextrin, or hydroxypropylmethylcellulose (HPMC)
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 |
|---|---|---|
| 9-5-1The investigational intervention is an oral food-supplement capsule combining curcumin, ginger, and piperine in a proprietary "9-5-1" ratio (curcuma extract : ginger extract : black pepper/piperine extract), administered as 4 capsules per day for 30 consecutive days prior to the race. | Dietary supplement | 9-5-1 |
| PlaceboCapsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions. | Dietary supplement | Control |
Primary outcome
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Time frame: From Day 30 (T1, end of the 30-day supplementation period) to race finish or withdrawal (T2) - up to approximately 60 hours later, corresponding to the maximum allowed race duration.
Knee pain is self-assessed using a Visual Analog Scale (VAS, 0-10 cm) at the end of the 30-day supplementation period (T1, day before the race) and immediately at race finish or withdrawal (T2). The primary outcome is the within-participant change in VAS score (T2 minus T1), compared between the curcumin-ginger-piperine (9-5-1) group and the placebo group.
11 secondary outcomes
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Time frame: (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in Joint Range of Motion (Ankles, Knees, Hips)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in Inflammatory biomarkers (ng/mL)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in serum enzyme activity (U/L)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Oxidative stress and adiponectin (µmol/L)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Changein serum creatinine (µmol/L)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in blood urea (mmol/L)
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Change in coagulation parameters
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Clinical tolerance
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Biological safety laboratory parameters
Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Joint Pains
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9-5-1 in people with Joint Pains, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 6 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas BOUSCAREN, Dr (+33262353530, Nicolas.BOUSCAREN@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale) (time frame: From Day 30 (T1, end of the 30-day supplementation period) to race finish or withdrawal (T2) - up to approximately 60 hours later, corresponding to the maximum allowed race duration.). 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 22 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.