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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07445503
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women 18-80 years of age,
* Overweight/obesity (body mass index \> 25 or waist circumference \>94 cm for males and \>80 cm for females), and
* The presence of at least one of the following metabolic abnormality: (1) triglyceride level ≥150 mg/dL or HDL cholesterol ≤40 mg/dL in men and ≤50 mg/dL in women; (2) increased blood pressure ≥ 130/85 mm Hg; (3) elevated fasting blood sugar ≥100 mg/dL; (4) standardized drug treatment regimen, and
* Provided signed informed consent for participation.
Exclusion Criteria:
* Concomitant acute or chronic disease (e.g., infection, cancer, chronic heart failure, kidney disease, autoimmune diseases like rheumatoid arthritis, inflammatory bowel diseases, Hashimoto),
* Untreated diabetes,
* Women at pregnancy or lactation,
* Individuals with psychiatric or mental disorder,
* Any use of antioxidant-phytochemical rich supplement, anti-, pre- or probiotics pre-intervention,
* Drug and/or alcohol abuse,
* Those who did not consent or were unable to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07445503
Study Brief:
Protocol Section:
NCT07445503