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

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• Arthralgia 277

Arthralgia

277 studies on the registry are indexed under Arthralgia; 54 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 218 interventional studies indexed under Arthralgia.

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Study arms

• Experimental
  9-5-1

  Dietary Supplement: 9-5-1

• Placebo comparator
  Control

  Dietary Supplement: Placebo

Interventions

• Dietary supplement9-5-1

  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.

• Dietary supplementPlacebo

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

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.

   Time frame: 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

1. Kinetics of Joint Pain Across the Study Period (Ankles, Knees, Hips)

   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.

   Time frame: (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

2. Change in Joint Range of Motion (Ankles, Knees, Hips)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

3. Change in circulating pro-inflammatory and anti-inflammatory cytokines (pg/mL)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

4. Change in Inflammatory biomarkers (ng/mL)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

5. Change in serum enzyme activity (U/L)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

6. Oxidative stress and adiponectin (µmol/L)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

7. Changein serum creatinine (µmol/L)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

8. Change in blood urea (mmol/L)

   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.

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

9. Change in coagulation parameters

   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

   Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

10. Clinical tolerance

    Clinical tolerance is assessed at each study visit by recording digestive symptoms, allergic reactions, and other adverse events.

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

11. Biological safety laboratory parameters

    Biological safety is assessed using routine laboratory parameters evaluating liver function, renal function, and coagulation throughout the study.

    Time frame: Baseline (T0, before supplementation) to Day 2 post-race or post-withdrawal (T3)

Individual participant data

Plan to share: No