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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant Sterols | Active Comparator | Plant Sterols |
|
| Placebo Product | Placebo Comparator | Placebo Product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant Sterols | Dietary Supplement |
| ||
| Placebo Product |
| Measure | Description | Time Frame |
|---|---|---|
| Change in flow-mediated dilation | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pulse wave velocity | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood lipids | At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention | |
| Change in plasma plant sterols | At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wieneke Koppenol, MSc | Unilever Research & Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28620471 | Derived | Ras RT, Fuchs D, Koppenol WP, Schalkwijk CG, Otten-Hofman A, Garczarek U, Greyling A, Wagner F, Trautwein EA. Effect of a plant sterol-enriched spread on biomarkers of endothelial dysfunction and low-grade inflammation in hypercholesterolaemic subjects. J Nutr Sci. 2016 Dec 6;5:e44. doi: 10.1017/jns.2016.40. eCollection 2016. | |
| 26806045 |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 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 central blood pressure | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Change in office blood pressure | At baseline (after 4 weeks run-in period) and after 12 weeks intervention |
| Ras RT, Koppenol WP, Garczarek U, Otten-Hofman A, Fuchs D, Wagner F, Trautwein EA. Increases in plasma plant sterols stabilize within four weeks of plant sterol intake and are independent of cholesterol metabolism. Nutr Metab Cardiovasc Dis. 2016 Apr;26(4):302-9. doi: 10.1016/j.numecd.2015.11.007. Epub 2015 Dec 12. |
| 25809853 | Derived | Ras RT, Fuchs D, Koppenol WP, Garczarek U, Greyling A, Keicher C, Verhoeven C, Bouzamondo H, Wagner F, Trautwein EA. The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. Am J Clin Nutr. 2015 Apr;101(4):733-41. doi: 10.3945/ajcn.114.102053. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |