Overview

This trial is active, not recruiting.

Condition hyperlipidemia
Treatments margarine + plant sterol esters, margarine (placebo)
Sponsor University Hospital, Saarland
Start date April 2009
End date June 2009
Trial size 16 participants
Trial identifier NCT00928616, 108/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants consume plant sterol ester supplemented margarine (3 g/day)
margarine + plant sterol esters plant sterols
margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
(Placebo Comparator)
Placebo is a non-sterol ester supplemented margarine
margarine (placebo) regular margarine
non-sterol ester supplemented margarine

Primary Outcomes

Measure
monocyte subpopulations
time frame: 4 weeks

Secondary Outcomes

Measure
serum parameters (lipids, plant sterol concentrations, inflammation parameters)
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - healthy individuals without known cardiovascular diseases Exclusion Criteria: - drugs that interfere with cholesterol metabolism - other use of dietary supplements - vegetarianism

Additional Information

Official title Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
Principal investigator Oliver Weingärtner, MD
Description This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by University Hospital, Saarland.