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
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • monocyte subpopulations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oliver Weingärtner MD, University of the Saarland
ClinicalTrials.gov Identifier: NCT00928616     History of Changes
Other Study ID Numbers: 108/07, 108/07
Study First Received: June 25, 2009
Last Updated: June 25, 2009
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 14, 2014