Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial (ECUM-RUN)
8 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Nicolas BOUSCAREN, Dr
- Telefoonnummer: +33262353530
- E-mail: Nicolas.BOUSCAREN@chu-reunion.fr
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Controle
|
Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
|
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Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Tijdsspanne: (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)
Tijdsspanne: 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.
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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)
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Change in serum enzyme activity (U/L)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
|
|
Change in coagulation parameters
Tijdsspanne: 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
Tijdsspanne: 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.
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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
Tijdsspanne: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
14 september 2026
Primaire voltooiing (Geschat)
20 oktober 2026
Studie voltooiing (Geschat)
20 oktober 2026
Studieregistratiedata
Eerst ingediend
2 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juli 2026
Eerst geplaatst (Werkelijk)
13 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
8 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025/RUN/0056
- 2026-A00478-43 (Andere identificatie: ID-RCB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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