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| Descriptive Information Fields | |||||||||
| Brief Title † | Concentration of Plant Sterols in Serum and Aortic Valve Cusps | ||||||||
| Official Title † | Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study | ||||||||
| Brief Summary | This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol). |
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| Detailed Description | The role of plant sterols in cardiovascular diseases is controversially debated. There is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. Functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. Numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. However, there are no studies available investigating relevant clinical endpoints. Nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. This study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Screening, Cross-Sectional, Defined Population, Prospective Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Aortic Valve Stenosis | ||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | September 2003 | ||||||||
| Completion Date | September 2005 | ||||||||
| Eligibility Criteria † | Inclusion Criteria: aortic valve stenosis - Exclusion Criteria:familial hypercholesterolemia. - |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00222950 | ||||||||
| Organization ID | Plant Sterols 159/04 | ||||||||
| Secondary IDs †† | 159/04 | ||||||||
| Study Sponsor † | University Hospital, Saarland | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University Hospital, Saarland | ||||||||
| Verification Date | September 2005 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | September 14, 2005 | ||||||||
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