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

Tracking Information

First Submitted Date

September 12, 2005

First Posted Date

September 22, 2005

Last Update Posted Date

September 22, 2005

Study Start Date

September 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Concentration of Plant Sterols in Serum and Aortic Valve Cusps

Official Title

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

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).

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 Type

Observational

Study Design

Observational Model: Defined Population
Time Perspective: Other

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition

Aortic Valve Stenosis

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

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. doi: 10.1016/j.jacc.2007.09.074.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Unknown status

Enrollment

100

Original Enrollment

Same as current

Study Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria

Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Older Adult

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Germany

Removed Location Countries

Administrative Information

NCT Number

NCT00222950

Other Study ID Numbers

Plant Sterols 159/04
159/04

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor

University Hospital, Saarland

Collaborators

Not Provided

Investigators

Principal Investigator:

Michael Bohm, Professor

University of the Saarland

PRS Account

University Hospital, Saarland

Verification Date

September 2005

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