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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02328235
Eligibility Criteria:
Inclusion Criteria:
* Males, age 18-40 years; BMI between 20 and 30 kg/m2. Weight stable for previous 6 months (± 2.0kg).
Sedentary to recreationally active (≤ 3 days, 20 min/day of walking type exercise, no planned exercise other than leisure walking for transportation purposes).
Verbal and written informed consent
non-smoking
Approved for participation by Medical Director (Jose Rivero, M.D.)
Exclusion Criteria:
* 1\. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
2\. Family history of diabetes
3\. BMI \> 30 kg/m2, blood pressure \> 140/90 mmHg or antihypertensive medications, fasting glucose \> 100 mg/dl, LDL cholesterol \> 130 mg/dl, total cholesterol \> 200 mg/dl, triglycerides \> 250 mg/dl.
4\. Verbal and written informed consent
4\. Smoking, alcohol consumption \> 2 servings/d, or taking medications (including but not limited to statins or other drugs with anti-inflammatory actions) or antioxidant vitamins or supplements, or know to affect carbohydrate or lipid metabolism.
5\. Total daily dietary fat consumption ≥ 35% and/or saturated fat consumption of ≥ 15%.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02328235
Study Brief:
Protocol Section:
NCT02328235