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.
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)
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
Parallel
9-5-1
Dietary supplementThe 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.
Placebo
Dietary supplementCapsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
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.
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.
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.
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.
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.
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