Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Study Overview
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Brief Summary
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Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.

Official Title
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Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product

Conditions
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Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Supplement product with plant stanol ester


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female over 18 years old serum LDL cholesterol > 3.0 mmol/L BMI < 35 subjects must voluntarily sign the informed consent Exclusion Criteria: subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy) subjects with any hepatic or renal disorder according to medical history subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening subjects who have history of temporal ischemic attack or stroke within six months prior to screening subjects who have a history of cancer or other malignant disease within the past five years subjects who are consuming more than 15 portions of alcohol / week subjects who are pregnant or lactating subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention subjects with intolerance to any ingredient of the test product

Ages Eligible for Study
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Minimum Age: 18 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: Supplement product with plant stanol ester<br> | Dietary Supplement: Supplement product with plant stanol ester<br>* 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks<br>|
| Placebo Comparator: Placebo supplement product<br> | Dietary Supplement: Supplement product with plant stanol ester<br>* 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportional change in serum LDL cholesterol | Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportional change in total cholesterol | Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks | 
| Proportional change in non-HDL-cholesterol | Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks | 
| Proportional change in serum triglycerides | Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks | 
| Proportional change in lipids in all study participants | Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis) | 3 to 4 weeks | 
| Proportional change in lipids in subjects without metabolic derangements | Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome) | 3 to 4 weeks |