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The Effect of Plant Sterols on Vascular Function

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ClinicalTrials.gov Identifier: NCT01803178
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Vascular Diseases Hypercholesterolemia Dietary Supplement: Plant Sterols Dietary Supplement: Placebo Product Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Plant Sterols on Vascular Function
Study Start Date : February 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Plant Sterols
Plant Sterols
 Dietary Supplement: Plant Sterols
Placebo Comparator: Placebo Product
Placebo Product
 Dietary Supplement: Placebo Product


Outcome Measures
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Primary Outcome Measures :
  1. Change in flow-mediated dilation [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]

Secondary Outcome Measures :
  1. Change in pulse wave velocity [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]

Other Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803178


Locations
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Germany
Charité Research Organisation
Berlin, Germany
Sponsors and Collaborators
Unilever R&D
Investigators
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Study Director: Wieneke Koppenol, MSc Unilever Research & Development
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01803178    
Other Study ID Numbers: FDS-SCC-0574
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: February 2013
Keywords provided by Unilever R&D:
vascular function
plant sterols
blood lipids
Additional relevant MeSH terms:
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Vascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases