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History of Changes for Study: NCT00222950
Concentration of Plant Sterols in Serum and Aortic Valve Cusps
Latest version (submitted September 14, 2005) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 14, 2005 None (earliest Version on record)
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Study NCT00222950
Submitted Date:  September 14, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: Plant Sterols 159/04
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
Secondary IDs: 159/04
Open or close this module Study Status
Record Verification: September 2005
Overall Status: Unknown status [Previously: Recruiting]
Study Start: September 2003
Primary Completion:
Study Completion: September 2005
First Submitted: September 12, 2005
First Submitted that
Met QC Criteria:
September 14, 2005
First Posted: September 22, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 14, 2005
Last Update Posted: September 22, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Saarland
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Aortic Valve Stenosis
Keywords: plant sterols, serum, aortic valve cusps
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Defined Population
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 100
Number of Groups/Cohorts 0
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Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 0 Years
Maximum Age: 0 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

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Open or close this module Contacts/Locations
Study Officials: Michael Bohm, Professor
Principal Investigator
University of the Saarland
Locations: Germany, Saarland
University of the Saarland
Homburg, Saarland, Germany, 66421
Contact:Contact: Oliver Weingartner, M.D. 0049-(0)68411623372 oweingartner@aol.com
Contact:Contact: Ulrich Laufs, M.D. 0049-(0)68411623372 ulrich@laufs.com
Contact:Sub-Investigator: Oliver Weingartner, M.D.
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Plan to Share IPD:
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