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

NCT ID: NCT00737919

Last Updated: 2011-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation

Group Type: ACTIVE_COMPARATOR

Plant Stanol

Intervention Type: DIETARY_SUPPLEMENT

Plant stanols in margarines daily 2 grams

2

A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation

Group Type: ACTIVE_COMPARATOR

Plant Sterol

Intervention Type: DIETARY_SUPPLEMENT

Plant sterols in margarines daily 2 grams

Interventions

Plant Stanol

Plant stanols in margarines daily 2 grams

Intervention Type: DIETARY_SUPPLEMENT

Plant Sterol

Plant sterols in margarines daily 2 grams

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Asymptomatic tight carotid plaques
• Age 40-80

Exclusion Criteria

• No

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Eastern Finland

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Surgery, Div of Vascular Surgery, Helsinki University Central Hospital

Principal Investigators

Tatu A. Miettinen, professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki

Helena Gylling, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland

Markku J Nissinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland

Locations

Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

215953

Identifier Type: -

Identifier Source: org_study_id