Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product

Launched by RAISIO GROUP · Sep 21, 2021

Keywords

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Gender

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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 such as Benecol, Becel pro.active, Keiju Alentaja 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