Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial

Centre Hospitalier Universitaire de la Réunion100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Joint Pains

Interventions

9-5-1DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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 Outcomes

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.

Time frame: (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.