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Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes (PSE-MO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by University Hospital, Saarland.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928616
First Posted: June 26, 2009
Last Update Posted: June 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Saarland
  Purpose
The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Condition Intervention
Hyperlipidemia Dietary Supplement: margarine + plant sterol esters Dietary Supplement: margarine (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • monocyte subpopulations [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • serum parameters (lipids, plant sterol concentrations, inflammation parameters) [ Time Frame: 4 weeks ]

Enrollment: 16
Study Start Date: April 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plant sterol esters
Participants consume plant sterol ester supplemented margarine (3 g/day)
Dietary Supplement: margarine + plant sterol esters
margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
Other Name: plant sterols
Placebo Comparator: Placebo
Placebo is a non-sterol ester supplemented margarine
Dietary Supplement: margarine (placebo)
non-sterol ester supplemented margarine
Other Name: regular margarine

Detailed Description:
This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy individuals without known cardiovascular diseases

Exclusion Criteria:

  • drugs that interfere with cholesterol metabolism
  • other use of dietary supplements
  • vegetarianism
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928616


Locations
Germany
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Oliver Weingärtner, MD Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
  More Information

Responsible Party: Oliver Weingärtner MD, University of the Saarland
ClinicalTrials.gov Identifier: NCT00928616     History of Changes
Other Study ID Numbers: 108/07
First Submitted: June 25, 2009
First Posted: June 26, 2009
Last Update Posted: June 26, 2009
Last Verified: June 2009

Keywords provided by University Hospital, Saarland:
hyperlipidemia
plant sterols
monocytes

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases