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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06314932
Eligibility Criteria:
Inclusion Criteria:
* age \>18 years
* BMI between 25.0 and 29.9 kg/m2 and the simultaneous presence of at least one of the following criteria, defined by the Guidelines for cardiovascular disease prevention of the European Society of Cardiology:
* total cholesterol levels \>190 mg/dL
* LDL-cholesterol levels \>115 mg/dL
* triglyceride levels \>150 mg/dL
* glucose levels in the range 111-125 mg/dL
Exclusion Criteria:
* presence of current serious illness or unstable condition that requires physician supervision of diet (e.g., recent myocardial infarction, chronic liver disease, inflammatory bowel diseases, renal or digestive disorders)
* pregnancy or intention to become pregnant in the next 12 months
* lactation
* current or recent (past 3 months) use of supplements or antibiotic therapy
* current or recent (past 6 months) adoption of specific restrictive diets (e.g., low-calorie or vegetarian diets)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06314932
Study Brief:
Protocol Section:
NCT06314932