Actively Recruiting
Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
Led by Fundació Eurecat · Updated on 2025-08-27
14
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
Fundació Eurecat
Lead Sponsor
C
Circe, S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants between 18 and 50 years old who are amateur runners
- Engage in at least 3 continuous running sessions per week, each lasting 60 minutes
- Able to run continuously for 45 minutes at high intensity without difficulty
- Provide signed informed consent before participating
- Able to read, write, and speak Catalan or Spanish
- High level of physical activity according to IPAQ: vigorous activity on at least 3 days per week with energy expenditure 500 MET-min/week
You will not qualify if you...
- Body mass index (BMI) less than or equal to 18 kg/m2 or greater than or equal to 30 kg/m2
- Chronic diseases associated with increased oxidative stress, such as diabetes, hypertension, COPD, or neurodegenerative diseases
- History of cardiovascular disease including heart attack, angina, stroke, or peripheral artery disease
- Use of antibiotics within 30 days before the study
- Use of medications or vitamin supplements exceeding recommended daily intake within 30 days before the study
- Use of polyphenol supplements, herbal extracts, or phytotherapeutic products within 30 days before the study
- Alcohol consumption of 4 or more standard drink units per day or 28 per week
- Active smoker
- Unintentional weight loss of more than 3 kg in the past 3 months
- Known food allergies or intolerances to study products
- Presence of anemia
- Presence of chronic gastrointestinal diseases in an active phase that may affect nutrient absorption
- History of cancer unless in complete remission at study start
- Participation in another drug or nutritional clinical trial within 30 days prior to study
- Inability to follow study guidelines
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fundació Eurecat
Reus, Tarragona, Spain, 43204
Actively Recruiting
Research Team
A
Antoni Caimari, PhD
CONTACT
A
Anna Crescenti, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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