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

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ClinicalTrials.gov Identifier: NCT00928616
Recruitment Status : Unknown
Verified June 2009 by University Hospital, Saarland.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2009
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
University Hospital, Saarland

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: margarine + plant sterol esters Dietary Supplement: margarine (placebo) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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.
Study Start Date : April 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Arm Intervention/treatment
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



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

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


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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

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

Responsible Party: Oliver Weingärtner MD, University of the Saarland
ClinicalTrials.gov Identifier: NCT00928616     History of Changes
Other Study ID Numbers: 108/07
108/07
First Posted: June 26, 2009    Key Record Dates
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