NCT00114907已完成不适用
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
研究概览
简要总结
It is proposed to investigate the association between consumption of black tea and various selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic heart diseases. This study, the first of its kind, will provide clinical data on the potential prophylactic propensities of Mauritian black tea against cardiovascular disease, which remains one of the major health threats to the Mauritian population.
详细描述
OBJECTIVES
Our broad objectives will be to:
- Survey and recruit patients with ischaemic heart diseases in a randomized sample representative of the Mauritian population (ethnicity, gender, age, social and economical status) and record their medical history,
- Collect fasting blood serum and urine at baseline and after supplement of control volume of tea infusion and water from study group and control group respectively,
- Optimize techniques to determine levels of specific biomarkers from above body fluid samples,
- Investigate existing correlation between tea consumption and risk of cardiovascular diseases in Mauritian population
Our specific objectives will be to:
- Select a randomised group of the Mauritian population, with ischaemic heart disease, who has been referred to the Cardiac Centre, Pamplemousses for Angiography and a group of people showing no risk of cardiovascular diseases
- Inform the people about the motives of the study and seek consent from those willing to participate in the study,
- Evaluate the levels of biomarkers of oxidative stress (total cholesterol, LDL, HDL, triglycerides, homocysteine, atrial natriuretic peptides, brain natriuretic peptides, 8-hydroxydeoxyguanosine, isoprostanes, hydroxyeicosatetraenoic acid, products of protein damage, uric acid and glycosylated haemoglobin) from 8-10 hr fasting blood serum and urine at baseline from all participants
- Supply the study group with a control volume of tea infusion and the control group with the same amount of water for a defined period of time followed by a two week wash out period with water.
- Study biomarkers as above from 8-10 hr fasting blood serum and urine in two week intervals during the supplement regime
- Investigate the existing correlation between tea consumption and levels of biomarkers of cardiovascular diseases in a Mauritian sample population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-70 years
- •Non smokers
- •Left ventricular ejection fraction>40%
排除标准
- •Alcohol consumption > 4 standard drinks/day
- •Postmenopausal women receiving hormone replacement therapy
结局指标
主要结局
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
次要结局
- The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
研究者
研究点 (2)
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