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

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: Plant Stanol; Dietary Supplement: Plant Sterol

• Registration Number: NCT00737919
• Lead Sponsor: University of Helsinki

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Asymptomatic tight carotid plaques
• Age 40-80

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Plant Stanol	A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation
2	Plant Sterol	A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation

Primary Outcome Measures

Name	Time	Method
Sterols in serum and carotid plaques at the operation	at operation and one month after operation

Trial Locations

Locations (1)

Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland