Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male participants between 18 and 50 years of age who are amateur runners. * Engage in at least 3 continuous running sessions per week, each lasting 60 minutes, which corresponds to a high level of physical activity according to the International Physical Activity Questionnaire (IPAQ).\* * Self-report being able to continuously run for 45 minutes at high intensity without difficulty. * Provide signed informed consent prior to participation in the study. * Able to read, write, and speak either Catalan or Spanish. * High level of physical activity according to the IPAQ: vigorous physical activity (such as running) on at least 3 days per week, with a total energy expenditure ≥1500 MET-min/week. MET value for vigorous activity = 8 × minutes × days per week. Exclusion Criteria: * Body Mass Index (BMI) ≤ 18 kg/m² or ≥ 30 kg/m². * Presence of chronic diseases associated with increased oxidative stress, such as diabetes, hypertension, chronic obstructive pulmonary disease