Dietary Phytosterols and Human Aortic Valve
关键词
抽象
描述
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.
日期
| 最后验证: | 01/31/2011 |
| 首次提交: | 08/19/2008 |
| 提交的预估入学人数: | 08/19/2008 |
| 首次发布: | 08/20/2008 |
| 上次提交的更新: | 02/10/2011 |
| 最近更新发布: | 02/13/2011 |
| 实际学习开始日期: | 03/31/2008 |
| 预计主要完成日期: | 11/30/2011 |
| 预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Dietary Supplement: A
Dietary Supplement: E
Dietary Supplement: C
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: A A group of patients consuming 2 grams plant stanols 4-8 weeks before the operation | Dietary Supplement: A 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: E Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation |
| Placebo Comparator: C | Dietary Supplement: C Margarine product without plant stanol or sterol esters |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Atherosclerotic aortic valve disease needing an aortic valve replacement operation Exclusion Criteria: - None |
结果
主要结果指标
1. Composition of serum and aortic valve sterols at the time of aortic valve operation [Up to 4 weeks]
