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

Primary Purpose

Hyperlipidemia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
margarine + plant sterol esters
margarine (placebo)
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring hyperlipidemia, plant sterols, monocytes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy individuals without known cardiovascular diseases

Exclusion Criteria:

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

Sites / Locations

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

plant sterol esters

Placebo

Arm Description

Participants consume plant sterol ester supplemented margarine (3 g/day)

Placebo is a non-sterol ester supplemented margarine

Outcomes

Primary Outcome Measures

monocyte subpopulations

Secondary Outcome Measures

serum parameters (lipids, plant sterol concentrations, inflammation parameters)

Full Information

First Posted
June 25, 2009
Last Updated
June 25, 2009
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT00928616
Brief Title
Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes
Acronym
PSE-MO
Official Title
Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
hyperlipidemia, plant sterols, monocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plant sterol esters
Arm Type
Experimental
Arm Description
Participants consume plant sterol ester supplemented margarine (3 g/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is a non-sterol ester supplemented margarine
Intervention Type
Dietary Supplement
Intervention Name(s)
margarine + plant sterol esters
Other Intervention Name(s)
plant sterols
Intervention Description
margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
margarine (placebo)
Other Intervention Name(s)
regular margarine
Intervention Description
non-sterol ester supplemented margarine
Primary Outcome Measure Information:
Title
monocyte subpopulations
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
serum parameters (lipids, plant sterol concentrations, inflammation parameters)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy individuals without known cardiovascular diseases Exclusion Criteria: drugs that interfere with cholesterol metabolism other use of dietary supplements vegetarianism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Weingärtner, MD
Organizational Affiliation
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

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Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes

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