Charité Research Organisation
Berlin, Germany
NCT Number: NCT01803178
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.
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Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Berlin, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Unilever R&D
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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