Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial (ECUM-RUN)
8 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nicolas BOUSCAREN, Dr
- Número de telefone: +33262353530
- E-mail: Nicolas.BOUSCAREN@chu-reunion.fr
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Ao controle
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Prazo: (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.
|
(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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Oxidative stress and adiponectin (µmol/L)
Prazo: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Clinical tolerance
Prazo: 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
Prazo: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
14 de setembro de 2026
Conclusão Primária (Estimado)
20 de outubro de 2026
Conclusão do estudo (Estimado)
20 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de julho de 2026
Primeira postagem (Real)
13 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/RUN/0056
- 2026-A00478-43 (Outro identificador: ID-RCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .