COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Plant Sterols on Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE March 4, 2013
Last Update Posted Date October 28, 2013
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
Change in flow-mediated dilation [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
Change in FMD [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
Change in pulse wave velocity [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
Change in PWV [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2013)
  • Change in blood lipids [ Time Frame: 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 ]
  • 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 ]
  • Change in aortic augmentation index [ Time Frame: 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 ]
  • Change in office blood pressure [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
Original Other Pre-specified Outcome Measures
 (submitted: February 28, 2013)
  • Change in blood lipids [ Time Frame: 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 ]
  • 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 ]
  • Change in Aix [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
  • Change in CBP [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
  • Change in office BP [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
 
Descriptive Information
Brief Title  ICMJE The Effect of Plant Sterols on Vascular Function
Official Title  ICMJE The Effect of Plant Sterols on Vascular Function
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Vascular Diseases
  • Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Plant Sterols
  • Dietary Supplement: Placebo Product
Study Arms  ICMJE
  • Active Comparator: Plant Sterols
    Plant Sterols
    Intervention: Dietary Supplement: Plant Sterols
  • Placebo Comparator: Placebo Product
    Placebo Product
    Intervention: Dietary Supplement: Placebo Product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2013)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01803178
Other Study ID Numbers  ICMJE FDS-SCC-0574
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wieneke Koppenol, MSc Unilever Research & Development
PRS Account Unilever R&D
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP