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

Hyperlipidemia Clinical Trial

— PSE-MO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00928616
• Other study ID #: 108/07
• Secondary ID: 108/07
• Status: Active, not recruiting
• Phase: N/A
• First received: June 25, 2009
• Last updated: June 25, 2009
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy individuals without known cardiovascular diseases

Exclusion Criteria:

• drugs that interfere with cholesterol metabolism

• other use of dietary supplements

• vegetarianism

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• margarine + plant sterol esters
margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
• margarine (placebo)
non-sterol ester supplemented margarine

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monocyte subpopulations		4 weeks	Yes
Secondary	serum parameters (lipids, plant sterol concentrations, inflammation parameters)		4 weeks	Yes