Not yet recruiting NCT07699575
Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 9-5-1, Placebo.
- Who it may be relevant to
- Registry conditions: Joint Pains. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement 9-5-1
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. - Dietary supplement Placebo
Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
Primary outcome measures
- 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.]
Secondary outcome measures (11)
- 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)]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07699575 · 2025/RUN/0056 · 2026-A00478-43