Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT07024966
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 (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 small spirit (25 mL); 2 SDUs correspond to 1 glass of brandy or liqueur (55 mL), 1 whiskey (70 mL), or a mixed drink (75 mL).
* 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 hernia, Crohn's disease, celiac disease, irritable bowel syndrome, diverticulitis, diverticulosis, chronic constipation, and ulcerative colitis.
\*\*Individuals with a history of cancer may be included only if they are in complete remission at the start of the study.
* Participation in another drug clinical trial or nutritional intervention study within 30 days prior to study inclusion.
* Inability to follow the study guidelines.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07024966
Study Brief:
Protocol Section:
NCT07024966