Concentration of Plant Sterols in Serum and Aortic Valve Cusps - Full Text View

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study

Official Title:	Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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, Saarland
	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 indexed to this study:

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.

Study ID Numbers:	Plant Sterols 159/04, 159/04
First Received:	September 12, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00222950
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:

plant sterols, serum, aortic valve cusps

Study placed in the following topic categories:

Heart Diseases

Constriction, Pathologic

Aortic valve stenosis

Aortic Valve Stenosis

Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University Hospital, Saarland
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00222950