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Completed

NCT Number: NCT01803178

The Effect of Plant Sterols on Vascular Function

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Research Organisation

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant Sterols

Dietary Supplement

Placebo product

Dietary Supplement

Primary outcomes

  1. Change in flow-mediated dilation

    Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Secondary outcomes

  1. Change in pulse wave velocity

    Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Other outcomes

  1. Change in blood lipids

    Time frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention

  2. Change in plasma plant sterols

    Time frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention

  3. 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

  4. Change in aortic augmentation index

    Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention

  5. Change in central blood pressure

    Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention

  6. Change in office blood pressure

    Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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