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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT06769035
Eligibility Criteria:
Inclusion criteria
1. Signed informed consent;
2. Men or women;
3. Age between 18 and 60 years;
4. Waist circumference ≥ 88 cm in women or ≥ 94 cm in men;
5. Plus one of the following criteria:
* BMI \>25 kg/m2 and not \> 30 kg/m2 in both genders or history of bariatric surgery \> 6 months;
* Fasting serum glucose of 100-125 mg/dL or HbA1c of 5.7-6.4% or on pharmacological treatment with OAD for prediabetes;
* Insulin resistance by HOMA \> 2.6 and insulin sensitivity by QUICKI \<0.34;F.
* Negative pregnancy test.
Exclusion criteria
1. On pharmacological treatment or diet for weight control;
2. Routine use of antioxidants in the last 3 months;
3. BMI ≥ 30 kg/m2 or recent bariatric surgery (\< 6 months);
4. LDL cholesterol \> 160 mg/dL or total cholesterol \> 200 mg/dL, and no treatment for dyslipidemia;
5. Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);
6. Pregnancy or breastfeeding;
7. Refusal to use an effective contraceptive method for the duration of the study;
8. Hypersensitivity to any of the components of the formula or phenylketonurics;
9. Endocrinological or rheumatic diseases;
10. Patient with recent initiation of vigorous physical exercise or exercise routine for weight loss and/or;
11. Liver or kidney failure by clinical and/or laboratory criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06769035
Study Brief:
Protocol Section:
NCT06769035