Vascular Diseases, Hypercholesterolemia
Conditions
Keywords
vascular function, plant sterols, blood lipids
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.
Interventions
DIETARY_SUPPLEMENTPlant Sterols
DIETARY_SUPPLEMENTPlacebo Product
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in flow-mediated dilation | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
Secondary
| Measure | Time frame |
|---|---|
| Change in pulse wave velocity | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
Other
| Measure | Time frame |
|---|---|
| Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Change in aortic augmentation index | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Change in blood lipids | At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention |
| Change in office blood pressure | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Change in central blood pressure | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Change in plasma plant sterols | At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention |
Countries
Germany
Outcome results
None listed