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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT01290250
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women,
and having altered at least two markers of MS namely:
* Hypertension (diastolic pressure higher than 85 mmHg but lower than 110 mmHg)
* Hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl)
* Elevated plasma triacylglycerol concentrations (higher than 150 mg/dl)
* Decreased plasma HDL-c levels (lower than 40 for men and 50 for women)
* Volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations.
Exclusion Criteria:
* The presence of morbid obesity
* Blood pressure higher than 110 mmHg
* Plasma glucose levels higher than 130 mg/dl
* The use of any medication for the control of blood pressure or glucose or lipid metabolism
* Medical history of consumption of hypocaloric diet in the last year
* Disorders of the food conduct
* The presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01290250
Study Brief:
Protocol Section:
NCT01290250