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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
Sponsor:
Information provided by:
University Hospital, Saarland

Study Description
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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).

Condition or disease
Aortic Valve Stenosis

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 Design
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Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study
Study Start Date : September 2003
Study Completion Date : September 2005

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

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Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222950


Contacts
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Contact: Oliver Weingartner, M.D. 0049-(0)68411623372 oweingartner@aol.com
Contact: Ulrich Laufs, M.D. 0049-(0)68411623372 ulrich@laufs.com

Locations
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Germany
University of the Saarland Recruiting
Homburg, Saarland, Germany, 66421
Contact: Oliver Weingartner, M.D.    0049-(0)68411623372    oweingartner@aol.com   
Contact: Ulrich Laufs, M.D.    0049-(0)68411623372    ulrich@laufs.com   
Sub-Investigator: Oliver Weingartner, M.D.         
Sponsors and Collaborators
University Hospital, Saarland
Investigators
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Principal Investigator: Michael Bohm, Professor University of the Saarland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00222950    
Other Study ID Numbers: Plant Sterols 159/04
159/04
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Keywords provided by University Hospital, Saarland:
plant sterols, serum, aortic valve cusps
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction