Effect of Plant Stanol Esters on Blood Lipids

Study Overview
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Brief Summary
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This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Detailed Description
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The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels. This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Official Title
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The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration

Conditions
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Elevated Blood Lipids

Intervention / Treatment
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* Dietary Supplement: plant stanol ester


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated blood lipids Body Mass Index < 35 kg/m2 Stable body weight Exclusion Criteria: Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism Severe obesity Hyperglycemia Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease) Hepatic, kidney or thyroid disease or disorder Pregnancy or breast feeding Severe intolerance or allergy to any ingredient of test product

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: yoghurt type minidrink containing plant stanol ester<br> | Dietary Supplement: plant stanol ester<br>* the effect of plant stanol esters on plasma lipids<br>|
| Placebo Comparator: yoghurt type minidrink without plant stanol ester<br> | Dietary Supplement: plant stanol ester<br>* the effect of plant stanol esters on plasma lipids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipids |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipoprotein lipids non-cholesterol sterols |  | 10 weeks |