Effects of Plant Stanol Esters on Blood Flow

Study Overview
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Brief Summary
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Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to 10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects. The purpose of the present study is to evaluate among healthy human subjects (N=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done. Hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.

Official Title
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Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

Conditions
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Atherosclerosis

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: healthy human subjects Exclusion Criteria: abnormal liver, kidney and thyroid function unstable myocardial disease inflammatory bowel disease alcohol abuse pregnancy any lipid-lowering medication

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plant stanol ester<br>3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months | Dietary Supplement: plant stanol ester<br>* 3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months<br>* Other names: Benecol;|
| Placebo Comparator: Placebo<br>a margarine product as part of daily diet, which is not containing plant stanol esters | Dietary Supplement: plant stanol ester<br>* 3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months<br>* Other names: Benecol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structure and function of the arterial wall |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum composition of fats |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, plant sterols, atherosclerosis, arterial stiffness