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Concentration of Plant Sterols in Serum and Aortic Valve Cusps

NCT ID: NCT00222950

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Aortic Valve Stenosis

Keywords

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plant sterols, serum, aortic valve cusps

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role lead

Principal Investigators

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Michael Bohm, Professor

Role: PRINCIPAL_INVESTIGATOR

University of the Saarland

Locations

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University of the Saarland

Homburg, Saarland, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Oliver Weingartner, M.D.

Role: CONTACT

Phone: 0049-(0)68411623372

Email: [email protected]

Ulrich Laufs, M.D.

Role: CONTACT

Phone: 0049-(0)68411623372

Email: [email protected]

Facility Contacts

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Oliver Weingartner, M.D.

Role: primary

Ulrich Laufs, M.D.

Role: backup

References

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Weingartner O, Lutjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, Konig J, Schafers HJ, Endres M, Bohm 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.

Reference Type DERIVED
PMID: 18420097 (View on PubMed)

Other Identifiers

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159/04

Identifier Type: -

Identifier Source: secondary_id

Plant Sterols 159/04

Identifier Type: -

Identifier Source: org_study_id