Concentration of Plant Sterols in Serum and Aortic Valve Cusps
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ClinicalTrials.gov Identifier: NCT00222950 |
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Saarland.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
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Sponsor:
University Hospital, Saarland
Information provided by:
University Hospital, Saarland
Tracking Information | ||||
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First Submitted Date | September 12, 2005 | |||
First Posted Date | September 22, 2005 | |||
Last Update Posted Date | September 22, 2005 | |||
Study Start Date | September 2003 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
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). | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Defined Population Time Perspective: Other |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Aortic Valve Stenosis | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Weingärtner O, Lütjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, König J, Schäfers HJ, Endres M, Böhm M, Laufs U. Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol. 2008 Apr 22;51(16):1553-61. doi: 10.1016/j.jacc.2007.09.074. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Enrollment |
100 | |||
Original Enrollment | Same as current | |||
Study Completion Date | September 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria: aortic valve stenosis - Exclusion Criteria:familial hypercholesterolemia. - |
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00222950 | |||
Other Study ID Numbers | Plant Sterols 159/04 159/04 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | University Hospital, Saarland | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University Hospital, Saarland | |||
Verification Date | September 2005 |