Status:
COMPLETED
The Effect of Plant Sterols on Vascular Function
Lead Sponsor:
Unilever R&D
Conditions:
Vascular Diseases
Hypercholesterolemia
Eligibility:
All Genders
40-65 years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01803178
Start Date
February 1 2013
End Date
August 1 2013
Last Update
October 28 2013
Active Locations (1)
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1
Charité Research Organisation
Berlin, Germany