The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Improvement of endothelial function as measured by FMD
研究概览
简要总结
The purpose of this study is to investigate whether a daily intake of dried broccoli sprouts will improve the endothelial function of the participants as measured by Flow mediated dilation (FMD)
The dried sprouts are chosen because broccoli sprouts are known as containing large amounts af the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have a positive effect on the endothelium as measured by NO release.
详细描述
Inflammation plays an important role in the development of atherosclerosis. The initial site of damage is the endothelium and secondarily the rest of the vascular wall is involved. Hypotheses concerning the development of these lesions have introduced the concept of oxidative stress, ("an imbalance between oxidants and antioxidants in favor of the oxidants, potentially leading to damage") as having a key role in the development of atherosclerosis. Consequently, much interest has been focused on attenuating oxidative stress in order to minimize this damage.
Clinical trials for the study of the effect of antioxidants on the atherosclerotic process, using micronutrients with a reductive potential, have failed to demonstrate a benefit for the patients and some have even shown an increased mortality.
An alternative is to induce the endogenous antioxidative defense of the cell. One possibility is to increase the expression of enzymes responsible for neutralizing oxidative substances, a group of enzymes relevant for this path are the phase 2 enzymes, for instance gluthation-s-transferase(GsT).
Broccoli sprouts have a very high content of Glucoraphanin(GP) a substance which has the ability to increase the expression of GsT.
Experiments involving stroke prone hypertensive rats and humans have indicated that GP in broccoli sprouts have a beneficial effect against oxidative stress. In the experiment with the rats a consequence of the protection against oxidative stress was an increase in endothelial dependant vasodilation(EDV). This finding is important because low EDV predicts development of atherosclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from hypertension, having a diastolic blood pressure of above 90 mm Hg or a systolic blood pressure of more than 140 mm Hg.
- •Patients suffering from NIDDM, according to present criteria for diagnosis of NIDDM:
- •People with dyslipidemia (combination of total cholesterol above 5, LDL cholesterol above 3 and HDL cholesterol below 1.1)
- •Healthy controls suffering from none of the above conditions, but otherwise (age, sex, BMI and lifestyle) corresponding to the patient groups.
排除标准
- •Patients under the age of 18 at inclusion in the study.
- •Pregnant or breastfeeding women
- •Women of childbearing age with no safe method of contraception
- •Patients receiving vitamin K-antagonists (coumarine, marcoumar etc)
结局指标
主要结局
Improvement of endothelial function as measured by FMD
次要结局
未报告次要终点
