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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07263802
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) 25.0-29.9 kg/m2
* FPG levels between 100 and 125 mg/dl \[IFG diagnosed after Oral Glucose Tolerance Test (OGTT)\]
* HOMA-IR \> 2.5
* subjects able to understand the informed consent and sign it before enrollment in the study
Exclusion Criteria:
* personal history of cardiovascular disease or equivalent risk factors
* obesity (BMI ≥ 30 kg/m²)
* taking hypoglycemic drugs or supplements that affect glycemic metabolism
* diabetes mellitus or IGT
* pregnancy or breastfeeding
* known thyroid, liver, kidney or muscle diseases
* any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent
* any known allergy or hypersensitivity to one or more components of the food supplement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT07263802
Study Brief:
Protocol Section:
NCT07263802