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

NCT ID: NCT00928616

Last Updated: 2009-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-06-30

Brief Summary

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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

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

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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plant sterol esters

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

Group Type EXPERIMENTAL

margarine + plant sterol esters

Intervention Type DIETARY_SUPPLEMENT

margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks

Placebo

Placebo is a non-sterol ester supplemented margarine

Group Type PLACEBO_COMPARATOR

margarine (placebo)

Intervention Type DIETARY_SUPPLEMENT

non-sterol ester supplemented margarine

Interventions

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margarine + plant sterol esters

margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks

Intervention Type DIETARY_SUPPLEMENT

margarine (placebo)

non-sterol ester supplemented margarine

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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plant sterols regular margarine

Eligibility Criteria

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Inclusion Criteria

* healthy individuals without known cardiovascular diseases

Exclusion Criteria

* drugs that interfere with cholesterol metabolism
* other use of dietary supplements
* vegetarianism
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role lead

Responsible Party

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University of the Saarland

Principal Investigators

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Oliver Weingärtner, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Locations

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Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Homburg, Saarland, Germany

Site Status

Countries

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Germany

Other Identifiers

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108/07

Identifier Type: -

Identifier Source: secondary_id

108/07

Identifier Type: -

Identifier Source: org_study_id

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