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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale) [Срок оценки: 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.]

Вторичные конечные точки (11)

• Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips) [Срок оценки: (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in Joint Range of Motion (Ankles, Knees, Hips) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in Inflammatory biomarkers (ng/mL) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in serum enzyme activity (U/L) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Oxidative stress and adiponectin (µmol/L) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Changein serum creatinine (µmol/L) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in blood urea (mmol/L) [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Change in coagulation parameters [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Clinical tolerance [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]
• Biological safety laboratory parameters [Срок оценки: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07699575 · 2025/RUN/0056 · 2026-A00478-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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