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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
June 25, 2009
June 26, 2009
June 26, 2009
April 2009
June 2009   (Final data collection date for primary outcome measure)
monocyte subpopulations [ Time Frame: 4 weeks ]
Same as current
No Changes Posted
serum parameters (lipids, plant sterol concentrations, inflammation parameters) [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes
Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
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.
This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • 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
  • Dietary Supplement: margarine (placebo)
    non-sterol ester supplemented margarine
    Other Name: regular margarine
  • Experimental: plant sterol esters
    Participants consume plant sterol ester supplemented margarine (3 g/day)
    Intervention: Dietary Supplement: margarine + plant sterol esters
  • Placebo Comparator: Placebo
    Placebo is a non-sterol ester supplemented margarine
    Intervention: Dietary Supplement: margarine (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
16
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy individuals without known cardiovascular diseases

Exclusion Criteria:

  • drugs that interfere with cholesterol metabolism
  • other use of dietary supplements
  • vegetarianism
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00928616
108/07
108/07
No
Not Provided
Not Provided
Oliver Weingärtner MD, University of the Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Oliver Weingärtner, MD Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
University Hospital, Saarland
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP