The Effect of Plant Sterols on Vascular Function

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Vascular Diseases
• Interventions: Dietary Supplement: Placebo Product; Dietary Supplement: Plant Sterols

• Registration Number: NCT01803178
• Lead Sponsor: Unilever R&D

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Product	Placebo Product	Placebo Product
Plant Sterols	Plant Sterols	Plant Sterols

Primary Outcome Measures

Name	Time	Method
Change in flow-mediated dilation	At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Secondary Outcome Measures

Name	Time	Method
Change in pulse wave velocity	At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Trial Locations

Locations (1)

Charité Research Organisation; 🇩🇪 Berlin, Germany