Lipid-lowering Effect of Plant Stanol Yogurt

Study Overview
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Brief Summary
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To determine the effect of investigational products on serum LDL cholesterol.

Detailed Description
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Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known. Study was monitored by Foodfiles

Official Title
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The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population

Conditions
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Hypercholesterolemia, Hyperlipidemias, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Yogurt that contains plant stanol esters
* Dietary Supplement: Placebo yogurt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects must voluntarily sign the informed consent subjects must be male or female aged 20 to 70 years subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week) Exclusion Criteria: subjects using lipid lowering medication subjects using ezetimibe subjects with bile acid sequestrant medication subjects with statin therapy subjects using other medication significantly influencing on lipid values subjects with diagnosis type 1 or type 2 diabetes severe obesity (BMI>35.0 kg/m2) serum fasting triglycerides > 4.0 mmol/l 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 with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase> 2 x upper limit, serum alkaline phosphatase> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician subjects who are consuming more than 15 portions of alcohol / week subjects who are pregnant or lactating subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2 subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products celiac disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yogurt that contains plant stanol esters<br>Dietary Supplement: Yogurt that contains plant stanol esters | Dietary Supplement: Yogurt that contains plant stanol esters<br> <br> |
| Placebo Comparator: Placebo yogurt<br>Dietary Supplement: Placebo yogurt | Dietary Supplement: Placebo yogurt<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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