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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT03429920
Eligibility Criteria:
Inclusion Criteria:
* Men and women 29-75 years of age
* At high risk for cardiovascular disease, i.e. with 2 or more risk factors:
* Present tobacco smoker
* Arterial hypertension (BP ≥ 140/90 mm Hg or treatment)
* LDL-cholesterol ≥ 110 mg/dl
* HDL-cholesterol ≤ 40 mg/dl
* Triglycerides ≥ 150 mg/dl
* Fasting blood glucose ≥ 110 mg/dl
* Overweight or obesity (BMI ≥ 25 kg/m2)
* Family history of premature heart disease
Exclusion Criteria:
* Uncontrolled renal, hepatic, or endocrine disease
* Abnormal blood chemistry profile
* Familial hypercholesterolemia or other genetic dyslipidemia
* Intake of lipid-lowering drugs and dietary products including plant sterols/stanols
* High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician
* Hypersensitive or allergic to soy or cellulose
* Alcohol or drug addiction or abuse
* Diabetes
* Lack of ability or interest to follow the dietary intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
29 Years
Maximum Age:
75 Years
Study:
NCT03429920
Study Brief:
Protocol Section:
NCT03429920