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临床试验/NCT00114907
NCT00114907已完成不适用

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

University of Mauritius2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2005年6月最近更新:
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

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

申办方类型
Other

研究点 (2)

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