Dietary Phytosterols and Human Aortic Valve

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Helsinki University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00738933
First received: August 20, 2008
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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 Intervention
Hypercholesterolemia
Atherosclerosis
Dietary Supplement: Dietary plant stanols
Dietary Supplement: Dietary plant sterols
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Composition of serum and aortic valve sterols at the time of aortic valve operation [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

Inclusion Criteria:

  • Atherosclerotic aortic valve disease needing an aortic valve replacement operation

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Markku Nissinen, MD PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00738933     History of Changes
Other Study ID Numbers: 231857
Study First Received: August 20, 2008
Last Updated: February 11, 2011
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014