Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2013-02-28
2013-08-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Plant Sterols
Plant Sterols
Plant Sterols
Placebo Product
Placebo Product
Placebo Product
Interventions
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Plant Sterols
Placebo Product
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
65 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Wieneke Koppenol, MSc
Role: STUDY_DIRECTOR
Unilever Research & Development
Locations
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Charité Research Organisation
Berlin, , Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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FDS-SCC-0574
Identifier Type: -
Identifier Source: org_study_id