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.
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.
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.
Crossover
Pterostilbene-silybin-nicotinamide riboside
Dietary supplementParticipants will take 2 sachets, each containing 340 mg of ccPT, silybin and nicotinamide riboside, and 1.91 g of excipients.
Control Group
Dietary supplementParticipants will take 2 sachets, each containing 340 mg microcrystalline cellulose, and 1.91 g of excipients.
Malondialdehyde (MDA) plasma levels
Plasma MDA levels will be measured using commercial ELISA kits
Age
The age of the volunteers will be recorded in the case report form.
Height (cm)
Height measured with standardized method
Body Weight (Kg)
Weight measured using the InBody 970 device
Body Mass Index (BMI) (Kg/m^2)
Weight and height will be combined to report BMI in kg/m\^2
Click on the lead sponsor to view all of their trials.
Fundació Eurecat
Lead sponsor
Circe, S.L.
Collaborator
