NCT00222950

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 14, 2005

Conditions

Aortic Valve Stenosis

Keywords

plant sterols, serum, aortic valve cusps

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Saarland

Homburg, Saarland, 66421, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18420097DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Michael Bohm, Professor

    University of the Saarland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Weingartner, M.D.

CONTACT

0049-(0)68411623372oweingartner@aol.com

Ulrich Laufs, M.D.

CONTACT

0049-(0)68411623372ulrich@laufs.com

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

September 1, 2003

Study Completion

September 1, 2005

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

DE(1)