Dietary Phytosterols and Human Aortic Valve
|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
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Atherosclerosis||Dietary Supplement: Dietary plant stanols Dietary Supplement: Dietary plant sterols Dietary Supplement: placebo||Not Applicable|
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|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- Composition of serum and aortic valve sterols at the time of aortic valve operation [ Time Frame: Up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738933
|Contact: Markku J. Nissinen, MD, PhD||+358 9 firstname.lastname@example.org|
|Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH)||Recruiting|
|Helsinki, Finland, 00029HUS|
|Contact: Markku Nissinen, MD, PhD +358 9 4711 email@example.com|
|Principal Investigator: Tatu A Miettinen, Professor|
|Sub-Investigator: Markku J Nissinen, MD, PhD|
|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|