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

Study Overview
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Brief Summary
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The aim is to determine the effect of investigational products on serum LDL cholesterol.

Official Title
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Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: Product that contains plant stanol ester
* Other: Placebo product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant stanol ester comparator<br>Product that contains plant stanol ester | Other: Product that contains plant stanol ester<br>* Product with active ingredient<br>|
| Placebo Comparator: Placebo comparator<br>Placebo product | Other: Placebo product<br>* Product without active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL cholesterol concentration (%) | Mean relative change in serum LDL cholesterol concentration during the intervention | 0 vs 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol concentration | Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group | 0 vs 3 weeks | 
| total cholesterol concentration | Changes in serum total cholesterol concentration during the intervention | 0 vs 3 weeks | 
| HDL cholesterol concentration | Changes in serum HDL cholesterol concentration during the intervention | 0 vs 3 weeks | 
| non-HDL cholesterol concentration | Changes in serum non-HDL cholesterol concentration during the intervention | 0 vs 3 weeks | 
| Total triglyceride concentration | Changes in serum triglycerides concentrations | 0 vs 3 weeks | 
| NMR blood biomarkers | Changes in specific NMR blood biomarkers | 0 vs 3 weeks |