Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males
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
- 1
- 主要终点
- 'Acute-upon-chronic Effect' of Tea vs Control
研究概览
简要总结
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
详细描述
Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers aged between >_30 _< 50 years of age
- •Body Mass Index (BMI) of >_18 and _< 25.0 kg/m2
- •Systolic blood pressure >_140 and >_100 mmHg and diastolic blood pressure < 90 and > 70 mmHg
- •Subjects who consume _< 2 cups of coffee per day
- •Subjects who drink tea regularly (>_ 2 cups per day)
- •Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
- •No prescribed medical treatment that may affect study parameters as judged by the Study Physician
- •Subject willing to abstain from alcohol on day before and on the day of assessment
- •Willing to sign the informed consent form
排除标准
- •Smokers and/or tobacco chewers
- •Those who consume regular alcohol (> 160 ml of alcohol per week)
- •Reported intense sport activities > 10h/week
- •Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit
研究组 & 干预措施
Control
Nutrition intervention study with a control
干预措施: Nutrition intervention study with a control (Other)
Tea extract
Nutrition intervention study with a black tea extract
干预措施: Nutrition intervention study with a black tea extract (Other)
结局指标
主要结局
'Acute-upon-chronic Effect' of Tea vs Control
时间窗: Baseline day 1 to 2 hours post consumption on day 8.
Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
次要结局
- Acute Effect of Tea vs Control(From baseline on day 1 to 2 hours post consumption on day 1)
- Chronic Effect of Tea vs Control(From baseline at day 1 to baseline on day 8)