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NCT00222950 Clinical Trial

Concentration of Plant Sterols in Serum and Aortic Valve Cusps

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00222950
Other study ID # Plant Sterols 159/04
Secondary ID 159/04
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated September 14, 2005
Start date September 2003
Est. completion date September 2005

Study information
Verified date September 2005
Source University Hospital, Saarland
Contact Oliver Weingartner, M.D.
Phone 0049-(0)68411623372
Email oweingartner@aol.com
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University of the Saarland Homburg Saarland

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

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