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OpenTrials
Completed

NCT Number: NCT00737919

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic tight carotid plaques
  • Age 40-80

Exclusion criteria

  • No

Treatment and study plan

Plant Stanol

Dietary Supplement

Plant stanols in margarines daily 2 grams

Plant sterol

Dietary Supplement

Plant sterols in margarines daily 2 grams

Primary outcomes

  1. Sterols in serum and carotid plaques at the operation

    Time frame: at operation and one month after operation

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • University of Eastern Finland

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
Registry last updated
Feb 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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