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

NCT00928616 — Not applicable, Unknown, 16 participants, University Hospital, Saarland

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Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.

Registry	NCT00928616, acronym PSE-MO
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	16 (Actual)
Sponsor	University Hospital, Saarland (Other)
Conditions	Hyperlipidemia
Interventions	margarine + plant sterol esters, margarine (placebo) (Dietary supplement)
Dates	start 2009-04-01, primary completion 2009-06-01 (estimated), completion 2009-06-01 (estimated), first posted 2009-06-26, last updated 2009-06-26
Locations	1 site in Germany

-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.

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
plant sterol esters	Experimental	Dietary Supplement: margarine + plant sterol esters	Participants consume plant sterol ester supplemented margarine (3 g/day)
Placebo	Placebo comparator	Dietary Supplement: margarine (placebo)	Placebo is a non-sterol ester supplemented margarine

margarine + plant sterol esters (Dietary supplement), also known as plant sterols: margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
margarine (placebo) (Dietary supplement), also known as regular margarine: non-sterol ester supplemented margarine

+Outcome measures

Primary outcomes

monocyte subpopulations [4 weeks]

Secondary outcomes

serum parameters (lipids, plant sterol concentrations, inflammation parameters) [4 weeks]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy individuals without known cardiovascular diseases

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III	Homburg, Saarland	Germany

+Investigators

Oliver Weingärtner, MD, Principal investigator, Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III