Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester

Study Overview
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Brief Summary
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The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.

Official Title
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Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids

Conditions
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Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Plant stanol ester
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Plant stanol ester<br>Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d). | Dietary Supplement: Plant stanol ester<br> <br> |
| Placebo Comparator: Placebo<br>Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d). | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in serum LDL cholesterol |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in serum LDL cholesterol (mmol/l) |  | 4 weeks | 
| Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides |  | 4 weeks |