The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level

Study Overview
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Brief Summary
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The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.

Detailed Description
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The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.

Official Title
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Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult

Conditions
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LDL-cholesterol Level 130-159mg/dL

Intervention / Treatment
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* Other: Yoghurt drink containing plant stanol as esters
* Other: Yoghurt drink without plant stanol as esters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications) Exclusion Criteria: taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs) history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease history or presence of cancer history of a psychiatric disorder and/or drug or alcohol abuse or dependency; having a known intolerance to gluten or lactose having a known allergy to any ingredient in the investigational product women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Subjects randomized to the test group consumed yoghurt drink containing 3.4g plant stanol as ester for 1 per day for a period of 4 weeks. | Other: Yoghurt drink containing plant stanol as esters<br> <br> |
| Placebo Comparator: Placebo group<br>Subjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks. | Other: Yoghurt drink without plant stanol as esters<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline LDL-cholesterol at 4-week |  | at baseline and 4-week follow-up | 
| Change from baseline total cholesterol at 4-week |  | at baseline and 4-week follow-up | 
| Change from baseline non-HDL-cholesterol at 4-week |  | at baseline and 4-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline triglyceride at 4-week |  | at baseline and 4-week follow-up | 
| Change from baseline HDL-cholesterol at 4-week |  | at baseline and 4-week follow-up | 
| Change from baseline Apolipoprotein A1 at 4-week |  | at baseline and 4-week follow-up | 
| Change from baseline Apolipoprotein B at 4-week |  | at baseline and 4-week follow-up |