Clinical Trial

Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress

Study acronym: PT-SILAOX
Recruiting
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Record status
This record was last updated August 27, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the effects of the dietary supplement ccPT-SIL-NR, which contains pterostilbene (ccPT), silybin (SIL), and nicotinamide riboside (NR), on oxidative stress markers after a high-intensity exercise session. The primary objective is to assess changes in blood malondialdehyde (MDA) levels. Secondary objectives include evaluating the effects on oxidative DNA damage (8-OHdG), lipid peroxidation (F2-isoprostanes), total antioxidant capacity (FRAP assay), glutathione ratio (GSH/GSSG), antioxidant enzyme activity (SOD, CAT, GPx), inflammatory markers (hsCRP, MCP-1, IL-6), muscle damage markers (LDH, CK), cortisol levels, renal function (creatinine), and gene expression patterns through transcriptomic analysis. The study will include 14 healthy male participants in a randomized, tripple-blind, placebo-controlled, crossover design. Each participant will receive both the ccPT-SIL-NR supplement and placebo for 14 days each, separated by a washout period of at least one week. A high-intensity exercise test will be performed at the end of each supplementation period. Total study duration per participant will be a minimum of 6 weeks.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-09; most recent amendment 2025-08-26.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT07024966
Lead Sponsor Fundació Eurecat
Collaborators: Circe, S.L.
Conditions Oxidative Stress, Physical Activity, Antioxidant Effect
Enrollment 14 participants
Start Date 2025-08-01
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-08-27