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 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
100
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Nicolas BOUSCAREN, Dr
- Telefonnummer: +33262353530
- E-Mail: Nicolas.BOUSCAREN@chu-reunion.fr
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Kontrolle
|
Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.
|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)
Zeitfenster: (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)
|
|
Change in Joint Range of Motion (Ankles, Knees, Hips)
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Change in Inflammatory biomarkers (ng/mL)
Zeitfenster: 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)
Zeitfenster: 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)
|
|
Oxidative stress and adiponectin (µmol/L)
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Changein serum creatinine (µmol/L)
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Change in blood urea (mmol/L)
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Change in coagulation parameters
Zeitfenster: 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)
|
|
Clinical tolerance
Zeitfenster: 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.
|
Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)
|
|
Biological safety laboratory parameters
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
14. September 2026
Primärer Abschluss (Geschätzt)
20. Oktober 2026
Studienabschluss (Geschätzt)
20. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
2. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juli 2026
Zuerst gepostet (Tatsächlich)
13. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025/RUN/0056
- 2026-A00478-43 (Andere Kennung: ID-RCB)
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