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New treatment option for Oxidative Stress
Official title Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
ClinicalTrials.gov ID: NCT07024966
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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.
- Use of medications or vitamin supplements that may interfere with the study supplement and exceed 100% of the recommended daily intake within 30 days...
- Use of polyphenol supplements, herbal extracts, or phytotherapeutic products that may interfere with the study treatment within 30 days prior to...
See the full eligibility 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 ×...
- 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.
- Use of medications or vitamin supplements that may interfere with the study supplement and exceed 100% of the recommended daily intake within 30 days prior to the start of the study.
- Use of polyphenol supplements, herbal extracts, or phytotherapeutic products that may interfere with the study treatment within 30 days prior to study start.
- Alcohol consumption of 4 or more Standard Drink Units (SDUs) per day or 28 SDUs per week.\ \ One SDU is defined as 10 grams of alcohol. This corresponds approximately to: 1 glass of wine (120 mL), 1 beer (330 mL), or 1...
- Active smoker.
- Unintentional weight loss of more than 3 kg in the past 3 months.
- Known food allergies and/or intolerances related to the study products.
- Presence of anemia.
- Presence of chronic gastrointestinal diseases\ or cancer.\ \ \ Chronic gastrointestinal diseases include those in an active phase that may interfere with nutrient absorption. Common examples include gastritis, hiatal...
- Participation in another drug clinical trial or nutritional intervention study within 30 days prior to study inclusion.
- Inability to follow the study guidelines.
The study team makes the final eligibility decision.
Where it's taking place
- Reus, Tarragona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reus, Tarragona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.