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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University Hospital, Saarland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00928616
First received: June 25, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 25, 2009
June 25, 2009
April 2009
June 2009   (final data collection date for primary outcome measure)
monocyte subpopulations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
serum parameters (lipids, plant sterol concentrations, inflammation parameters) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00928616
108/07, 108/07
No
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