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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02354794
Eligibility Criteria:
Inclusion Criteria :
* Age between 18 to 60 years old
* Overweight (BMI between 25 and 30 kg/m²)
* 'Hypertriglyceridemic waist' (waist circumference \> 94cm for men or \> 88cm for women and fasting triglyceride levels \> 150 mg/dL)
Exclusion Criteria :
* Obesity (BMI\> 30 kg / m²)
* Cardiac or vascular diseases
* Diabetes
* Thyroid disease
* Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg
* Tobacco consumption \> 6 cigarettes per week
* Alcohol consumption\> 2 drinks per day
* Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study.
* Persons under guardianship
* Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV
* Hemoglobin \< 14 g/dl (for men) or \<12 g / dl (for women)
* Participation in a clinical trial within 6 months preceding the study
* Pregnant and lactating women
* For women, menstrual cycle with a duration different from 28 (± 1) days (the cycle is not controlled by a contraceptive treatment at 28 days, or he does not appear spontaneously with regularity)
* Subjects with allergies to final product components
* Contraindications to arginine intake, namely asthmatics subjects, people prone to herpes, patients with liver cirrhosis and renal failure
* Hypotensive patients for whom the use of nitroglycerin is contraindicated.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02354794
Study Brief:
Protocol Section:
NCT02354794