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NCT Number: NCT07699575

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

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.

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Key information

Conditions

Joint Pains Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

9-5-1

Dietary 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.

Placebo

Dietary Supplement

Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. Change in Joint Range of Motion (Ankles, Knees, Hips)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  3. 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)

    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.

  4. Change in Inflammatory biomarkers (ng/mL)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  5. Change in serum enzyme activity (U/L)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  6. Oxidative stress and adiponectin (µmol/L)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  7. Changein serum creatinine (µmol/L)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  8. Change in blood urea (mmol/L)

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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.

  9. Change in coagulation parameters

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    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

  10. Clinical tolerance

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    Clinical tolerance is assessed at each study visit by recording digestive symptoms, allergic reactions, and other adverse events.

  11. Biological safety laboratory parameters

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

    Biological safety is assessed using routine laboratory parameters evaluating liver function, renal function, and coagulation throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas BOUSCAREN, Dr

CONTACT

[email protected]

+33262353530

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: ECUM-RUN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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