The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Plant Stanol
Plant Sterol
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Cholesterol, Plant sterols, Atherosclerotic carotid plaques
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic tight carotid plaques
- Age 40-80
Exclusion Criteria:
- No
Sites / Locations
- Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation
A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation
Outcomes
Primary Outcome Measures
Sterols in serum and carotid plaques at the operation
Secondary Outcome Measures
Full Information
NCT ID
NCT00737919
First Posted
August 19, 2008
Last Updated
February 9, 2011
Sponsor
University of Helsinki
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT00737919
Brief Title
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Official Title
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
University of Eastern Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Cholesterol, Plant sterols, Atherosclerotic carotid plaques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation
Arm Title
2
Arm Type
Active Comparator
Arm Description
A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant Stanol
Intervention Description
Plant stanols in margarines daily 2 grams
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant Sterol
Intervention Description
Plant sterols in margarines daily 2 grams
Primary Outcome Measure Information:
Title
Sterols in serum and carotid plaques at the operation
Time Frame
at operation and one month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Asymptomatic tight carotid plaques
Age 40-80
Exclusion Criteria:
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatu A. Miettinen, professor
Organizational Affiliation
Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helena Gylling, Professor
Organizational Affiliation
Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku J Nissinen, MD, PhD
Organizational Affiliation
Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
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