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

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ClinicalTrials.gov Identifier: NCT00737919
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : February 10, 2011
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Helsinki University

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Dietary Supplement: Plant Stanol Dietary Supplement: Plant Sterol Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Study Start Date : May 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation
Dietary Supplement: Plant Stanol
Plant stanols in margarines daily 2 grams
Active Comparator: 2
A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation
Dietary Supplement: Plant Sterol
Plant sterols in margarines daily 2 grams



Primary Outcome Measures :
  1. Sterols in serum and carotid plaques at the operation [ Time Frame: at operation and one month after operation ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic tight carotid plaques
  • Age 40-80

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737919


Locations
Finland
Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University
University of Eastern Finland
Investigators
Principal Investigator: Tatu A. Miettinen, professor Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki
Principal Investigator: Helena Gylling, Professor Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland
Principal Investigator: Markku J Nissinen, MD, PhD Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland

Responsible Party: Professor Mauri Lepäntalo, Dept. of Surgery, Div of Vascular Surgery, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00737919     History of Changes
Other Study ID Numbers: 215953
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: February 10, 2011
Last Verified: August 2008

Keywords provided by Helsinki University:
Cholesterol
Plant sterols
Atherosclerotic carotid plaques

Additional relevant MeSH terms:
Atherosclerosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical