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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 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
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, see Learn About Clinical Studies.

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 November 25, 2014