The Effect of Plant Sterols on Vascular Function

Study Overview
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Brief Summary
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The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD). This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP), blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed. For all study outcomes, effect sizes and 95% confidence intervals will be estimated. Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly increase FMD.

Detailed Description
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Plant sterols are well known for their LDL-cholesterol lowering benefit. Elevated cholesterol and especially LDL-cholesterol concentrations are established risk factors for coronary heart disease (CHD) and reducing these concentrations by dietary modification or drug treatment have been shown to reduce the risk of CHD. Direct evidence supporting a reduced risk of CHD has so far not been generated. Investigating the effects of consuming plant sterols on intermediate risk factors beyond cholesterol-lowering is therefore warranted.

Official Title
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The Effect of Plant Sterols on Vascular Function

Conditions
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Vascular Diseases, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Plant Sterols
* Dietary Supplement: Placebo Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy men and post-menopausal women BMI ≥ 18 and ≤ 30 kg/m2. Aged between 40 - 65 years. Having elevated LDL-cholesterol concentrations at screening (130-190 mg/dL or 3.4-4.9 mmol/L). Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician Exclusion Criteria: Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus. Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, ARB and ACE inhibitors), to be judged by the Principal Investigator. Use of medical treatment for elevated TG concentrations. Use of antibiotics in the three months prior to screening. Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant Sterols<br>Plant Sterols | Dietary Supplement: Plant Sterols<br> <br> |
| Placebo Comparator: Placebo Product<br>Placebo Product | Dietary Supplement: Placebo Product<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in flow-mediated dilation |  | At baseline (after 4 weeks run-in period) and after 12 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pulse wave velocity |  | At baseline (after 4 weeks run-in period) and after 12 weeks intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function, plant sterols, blood lipids