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The Effect of Plant Sterols on Vascular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01803178
First received: February 26, 2013
Last updated: October 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Vascular Diseases
Hypercholesterolemia
Dietary Supplement: Plant Sterols
Dietary Supplement: Placebo Product

Study Type: Interventional
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
Official Title: The Effect of Plant Sterols on Vascular Function

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Change in flow-mediated dilation [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pulse wave velocity [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in blood lipids [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ] [ Designated as safety issue: No ]
  • Change in plasma plant sterols [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in aortic augmentation index [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ] [ Designated as safety issue: No ]
  • Change in central blood pressure [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ] [ Designated as safety issue: No ]
  • Change in office blood pressure [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: February 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plant Sterols
Plant Sterols
Dietary Supplement: Plant Sterols
Placebo Comparator: Placebo Product
Placebo Product
Dietary Supplement: Placebo Product

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803178

Locations
Germany
Charité Research Organisation
Berlin, Germany
Sponsors and Collaborators
Unilever R&D
Investigators
Study Director: Wieneke Koppenol, MSc Unilever Research & Development
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01803178     History of Changes
Other Study ID Numbers: FDS-SCC-0574
Study First Received: February 26, 2013
Last Updated: October 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Unilever R&D:
vascular function
plant sterols
blood lipids

Additional relevant MeSH terms:
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014