Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial (ECUM-RUN)
8 de julio de 2026 actualizado por: Centre Hospitalier Universitaire de la Réunion
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nicolas BOUSCAREN, Dr
- Número de teléfono: +33262353530
- Correo electrónico: Nicolas.BOUSCAREN@chu-reunion.fr
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Control
|
Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
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Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Periodo de tiempo: 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.
|
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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Periodo de tiempo: (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.
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(T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
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Change in Joint Range of Motion (Ankles, Knees, Hips)
Periodo de tiempo: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
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Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Change in Inflammatory biomarkers (ng/mL)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Change in serum enzyme activity (U/L)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Oxidative stress and adiponectin (µmol/L)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Changein serum creatinine (µmol/L)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Change in blood urea (mmol/L)
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
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Change in coagulation parameters
Periodo de tiempo: 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
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Clinical tolerance
Periodo de tiempo: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Clinical tolerance is assessed at each study visit by recording digestive symptoms, allergic reactions, and other adverse events.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Biological safety laboratory parameters
Periodo de tiempo: 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.
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Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
14 de septiembre de 2026
Finalización primaria (Estimado)
20 de octubre de 2026
Finalización del estudio (Estimado)
20 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/RUN/0056
- 2026-A00478-43 (Otro identificador: ID-RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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