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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT03284918
Eligibility Criteria:
Inclusion Criteria:
* Serum total cholesterol 5.2-8.5 mmol/l
* Serum triglycerides \< 3 mmol/l
* Signed written informed consent
Exclusion Criteria:
* Abnormal liver, kidney and thyroid function
* Use of lipid lowering medication
* Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* History of recent temporal ischemic attack or malignant diseases (\< 5 yrs)
* Celiac disease, or allergy or intolerance to the ingredients of the test products
* Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
* Subjects with alcohol abuse (\> 4 portion per day)
* Pregnancy or planned pregnancy or lactating
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03284918
Study Brief:
Protocol Section:
NCT03284918