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Concentration of Plant Sterols in Serum and Aortic Valve Cusps

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Saarland.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222950
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Saarland
  Purpose
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
Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Estimated Enrollment: 100
Study Start Date: September 2003
Estimated Study Completion Date: September 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

  Contacts and Locations
Information from the National Library of Medicine

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

Locations
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
Principal Investigator: Michael Bohm, Professor University of the Saarland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00222950     History of Changes
Other Study ID Numbers: Plant Sterols 159/04
159/04
First Submitted: September 12, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by University Hospital, Saarland:
plant sterols, serum, aortic valve cusps

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction