The Effect of Plant Sterols on Vascular Function

Hypercholesterolemia Clinical Trial

Official title:

The Effect of Plant Sterols on Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803178
• Other study ID #: FDS-SCC-0574
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: October 25, 2013
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: February 2013
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercholesterolemia
• Vascular Diseases

Intervention

Dietary Supplement:
• Plant Sterols

• Placebo Product

Locations

Country	Name	City	State
Germany	Charité Research Organisation	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood lipids		At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention	No
Other	Change in plasma plant sterols		At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention	No
Other	Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No
Other	Change in aortic augmentation index		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No
Other	Change in central blood pressure		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No
Other	Change in office blood pressure		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No
Primary	Change in flow-mediated dilation		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No
Secondary	Change in pulse wave velocity		At baseline (after 4 weeks run-in period) and after 12 weeks intervention	No