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

June 25, 2009 updated by: University Hospital, Saarland

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy individuals without known cardiovascular diseases

Exclusion Criteria:

  • drugs that interfere with cholesterol metabolism
  • other use of dietary supplements
  • vegetarianism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • plant sterols
Placebo Comparator: Placebo
Placebo is a non-sterol ester supplemented margarine
Dietary supplement: margarine (placebo)
non-sterol ester supplemented margarine
Other Names:
  • regular margarine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
monocyte subpopulations
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
serum parameters (lipids, plant sterol concentrations, inflammation parameters)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Oliver Weingärtner, MD, Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

June 26, 2009

Last Update Submitted That Met QC Criteria

June 25, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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