Flow Mediated Dilation in Response to Consumption of Black Tea Versus Artificial Tea, in Non-tea Drinking Hypertensive Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Flow Mediated Dilation
研究概览
简要总结
Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.
详细描述
Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and post menopausal (> 1 year) females, not on hormone replacement therapy
- •Aged >18 and < 65 years
- •Body mass index (BMI) of >=18.0 and =<35.0 kg/m2
- •Hypertension as previously diagnosed by primary care or hospital physician.
- •If untreated, office BP between 140/90 mmHg and 160/100 mmHg on screening
- •If treated, a controlled blood pressure (<160/100) on stable medication for at least 4 weeks
排除标准
- •Tea drinkers: having typically consumed > 1 cup of black tea per week.
- •Current smoker or has stopped smoking less than 6 months before start of study
- •Self reported alcohol intake of >21 units/week
- •Established cardiovascular disease other than hypertension
- •Clinically significant arrhythmia
- •Diabetes mellitus
- •Chronic Kidney Disease > stage 2
- •10-year cardiovascular risk equivalent to 20% or greater using the QRisk2 calculator
- •Abnormality of laboratory blood tests considered clinically significant
- •Any other significant intercurrent condition/disease
结局指标
主要结局
Flow Mediated Dilation
时间窗: Before and 2 hours after test product intake
Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software: * 1 minute baseline scan to measure the baseline diameter of artery * 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter
次要结局
- Systolic Blood Pressure Supine(Before and 110 minutes after test product intake)
- Systolic Blood Pressure Sitting(Before and 90 minutes after test product intake)
- Diastolic Blood Pressure Sitting(Before and 90 minutes after test product intake)
- Diastolic Blood Pressure Supine(Before and 110 minutes after test product intake)
- Endothelium-independent Vasodilation(2.5 hours after test product intake)