NCT01803178

The Effect of Plant Sterols on Vascular Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Diseases
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant Sterols
DIETARY_SUPPLEMENT	Placebo Product

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-03-04
• Last updated: 2013-10-28

Locations

1 site across 1 country: Germany