Concentration of Plant Sterols in Serum and Aortic Valve Cusps

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Saarland. Recruitment status was Recruiting

First Received on September 12, 2005. Last Updated on September 14, 2005 History of Changes

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

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:

Drug Information available for: beta-Sitosterol Campesterol

U.S. FDA Resources

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.

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
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

No publications provided by University Hospital, Saarland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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

ClinicalTrials.gov processed this record on February 12, 2012