Anti-inflammatory Effects of Curcumin, Ginger and Piperine Supplementation in Ultra-trail Runners: a Double-blind Randomized Placebo-controlled Trial

NCT07699575 | Not Yet Recruiting

• 2 other identifiers: 2025/RUN/00562026-A00478-43
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Joint Pains

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain Intensity from End of Supplementation to Race Finish (Visual Analog Scale)

  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.

Secondary Outcomes (11)

• 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 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)

• Change in Inflammatory biomarkers (ng/mL)

  Baseline (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)

Study Arms (2)

9-5-1

EXPERIMENTAL

Dietary Supplement: 9-5-1

Control

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

9-5-1 DIETARY_SUPPLEMENT

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.

9-5-1

Placebo DIETARY_SUPPLEMENT

Capsule excipients are maltodextrin and hydroxypropylmethylcellulose (HPMC), allowing an identical-appearing placebo for double-blind conditions.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas BOUSCAREN, Dr

CONTACT

+33262353530; Nicolas.BOUSCAREN@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share