Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control
干预措施: Placebo (Dietary Supplement)
9-5-1
干预措施: 9-5-1 (Dietary Supplement)
结局指标
主要结局
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
时间窗: 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.
次要结局
- Change in Inflammatory biomarkers (ng/mL)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Change in Joint Range of Motion (Ankles, Knees, Hips)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)((T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Change in serum enzyme activity (U/L)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Oxidative stress and adiponectin (µmol/L)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Changein serum creatinine (µmol/L)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Change in blood urea (mmol/L)(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Change in coagulation parameters(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Clinical tolerance(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))
- Biological safety laboratory parameters(Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3))