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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorFundació Eurecat

About this trial

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

Qualifiers

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.

Disqualifiers

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 (COPD), or neurodegenerative diseases.

Personal history of cardiovascular disease, including myocardial infarction, angina pectoris, stroke, or peripheral artery disease.

Use of antibiotics within 30 days prior to study entry.

Trial design

Treatments tested in this trial

  • Pterostilbene-silybin-nicotinamide riboside
  • Control Group

Treatment groups

14 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fundació Eurecat

Lead sponsor

Circe, S.L.

Collaborator