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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT05126056
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
* Plasma triglyceride levels ≤ 4.0 mmol/l
* Age 18-65 years
Exclusion Criteria:
* Intolerance to oats or other ingredients of the test products
* Severe obesity (BMI ≥ 32 kg/m2)
* Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
* Consumption of plant stanol or plant sterol containing food products or supplements or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
* History of malignant diseases like cancer within five years prior to recruitment
* 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
* Celiac disease
* Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
* Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
* Pregnancy or planned pregnancy or lactating
* Clinically significant abnormalities in screening labs
* Participation in another clinical trial in the preceding 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05126056
Study Brief:
Protocol Section:
NCT05126056