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

Raisio Group

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: Placebo product; Other: Product that contains plant stanol ester

Study type: Interventional

Funder types: Industry

Identifiers

NCT05064644

NGH1

Details and patient eligibility

About

The aim is to determine the effect of investigational products on serum LDL cholesterol.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Plant stanol ester comparator

Active Comparator group

Description:

Product that contains plant stanol ester

Treatment:

Other: Product that contains plant stanol ester

Placebo comparator

Placebo Comparator group

Description:

Placebo product

Treatment:

Other: Placebo product