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NCT00737919 Clinical Trial

The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

Atherosclerosis Clinical Trial

Official title:
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00737919
Other study ID # 215953
Secondary ID
Status Completed
Phase N/A
First received August 19, 2008
Last updated February 9, 2011
Start date May 2006
Est. completion date December 2009

Study information
Verified date August 2008
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.

Description:

This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols.

This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Asymptomatic tight carotid plaques

- Age 40-80

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Plant Stanol
Plant stanols in margarines daily 2 grams
• Plant Sterol
Plant sterols in margarines daily 2 grams

Locations
Country Name City State
Finland Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital Helsinki

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sterols in serum and carotid plaques at the operation at operation and one month after operation Yes
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