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

This study has been completed.
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00737919
First received: August 19, 2008
Last updated: February 9, 2011
Last verified: August 2008
History of Changes
  Purpose

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 Intervention
Atherosclerosis
 Dietary Supplement: Plant Stanol
Dietary Supplement: Plant Sterol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Sterols in serum and carotid plaques at the operation [ Time Frame: at operation and one month after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic tight carotid plaques
  • Age 40-80

Exclusion Criteria:

  • No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 19, 2008
Last Updated: February 9, 2011
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013