The Effect of Plant Sterols on Vascular Function

October 25, 2013 updated by: Unilever R&D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité Research Organisation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plant Sterols
Dietary supplement: Plant Sterols
Placebo Comparator: Placebo Product
Dietary supplement: Placebo Product

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Change in blood lipids
Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Change in plasma plant sterols
Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation
Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Change in aortic augmentation index
Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Change in central blood pressure
Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Change in office blood pressure
Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Study Director: Wieneke Koppenol, MSc, Unilever Research & Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDS-SCC-0574

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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