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Dietary Phytosterols and Human Aortic Valve

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ClinicalTrials.gov Identifier: NCT00738933
Recruitment Status : Unknown
Verified February 2011 by Helsinki University.
Recruitment status was:  Recruiting
First Posted : August 21, 2008
Last Update Posted : February 14, 2011
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Helsinki University

Brief Summary:
This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ. Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a margarine product.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Atherosclerosis Dietary Supplement: Dietary plant stanols Dietary Supplement: Dietary plant sterols Dietary Supplement: placebo Not Applicable

Detailed Description:

High level of serum cholesterol is a risk factor for atherosclerotic complications, including atherosclerotic aortic valve disease. Over 50 years dietary plant sterols have been used to inhibit intestinal cholesterol absorption and to decrease its levels in serum. Daily human diet contains numerous different plant sterols, of which sitosterol and campesterol are the most abundant ones. Few epidemiologic studies suggest that sitosterol and campesterol may also be involved in formation of atherosclerotic changes in human arteries. The saturated forms of sitosterol and campesterol, i.e., the plant stanols (mainly sitostanol and campestanol) are beneficial with this respect. As part of daily diet, the plant stanols decrease absorption of both cholesterol and plant sterols, and thus, are putatively even more effective in prevention of atherosclerosis than the respective plant sterols.

Our double-blind controlled intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve.

50-60 patients, who will undergo aortic valve surgery, will be asked to volunteer our study. The patients will be randomized into three groups: (A) a group consuming margarine containing daily 2 grams plant stanols, (E) a group consuming margarine containing daily 2 grams of plant sterols, (C) a control group consuming margarine without any plant sterols or stanols. The dietary intervention will last for 4 to 8 weeks from the randomization to the operation.

Serum samples for analyses of serum lipids, lipoproteins and sterols will be collected at the randomization and at the operation. The atherosclerotic aortic valve will be examined with respect to its composition of cholesterol, other sterols and stanols.

The aim of our study is to elucidate the effects of dietary consumption of plant sterols and stanols on the sterol composition and structure of the atherosclerotic disease-affected aortic valve in human patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve
Study Start Date : April 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: A
A group of patients consuming 2 grams plant stanols 4-8 weeks before the operation
Dietary Supplement: Dietary plant stanols
Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation
Active Comparator: E
A group of patients consuming daily 2 grams plant sterols 4-8 weeks before the operation.
Dietary Supplement: Dietary plant sterols
Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation
Placebo Comparator: C Dietary Supplement: placebo
Margarine product without plant stanol or sterol esters



Primary Outcome Measures :
  1. Composition of serum and aortic valve sterols at the time of aortic valve operation [ Time Frame: Up to 4 weeks ]


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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:

  • Atherosclerotic aortic valve disease needing an aortic valve replacement operation

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): NCT00738933


Contacts
Contact: Markku J. Nissinen, MD, PhD +358 9 4711 markku.nissinen@hus.fi

Locations
Finland
Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH) Recruiting
Helsinki, Finland, 00029HUS
Contact: Markku Nissinen, MD, PhD    +358 9 4711    markku.nissinen@hus.fi   
Principal Investigator: Tatu A Miettinen, Professor         
Sub-Investigator: Markku J Nissinen, MD, PhD         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markku Nissinen, MD PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00738933     History of Changes
Other Study ID Numbers: 231857
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by Helsinki University:
Atherosclerosis
Plant sterols
Plant stanols
Aortic valve

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases