跳至主要内容
临床试验/NCT02328339
NCT02328339已完成不适用

Forearm Blood Flow Response to Acute Consumption of Black Tea

Unilever R&D0 个研究点目标入组 20 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Forearm blood flow response to acetylcholine

研究概览

简要总结

The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design.

详细描述

Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation.

Less is known however about its effects in other vascular beds. The study will test the hypothesis that tea affects endothelial function in the muscle microcirculation. This will be done by assessment of forearm blood flow using venous occlusion plethysmography after consumption of black tea against or placebo in a randomised, full cross-over study in 20 healthy middle-aged to elderly subjects

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and post menopausal (> 1 years) females
  • Aged ≥ 45 and ≤ 75 years
  • Body mass index (BMI) of ≥ 18.0 and ≤ 35.0 kg/m2
  • Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).
  • Normal blood coagulation as assessed by routine lab tests

排除标准

  • Strenuous exercise > 2 hours per week. Strenuous exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation
  • 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 or clinically significant arrhythmia
  • Diabetes mellitus
  • Blood pressure > 160/100 mmHg
  • Taking medication that might affect endothelial function (as judged by the PI)

结局指标

主要结局

Forearm blood flow response to acetylcholine

时间窗: During acetylcholine infusion 120-140 min after first tea/placebo intake

Does tea ingestion change mean forearm blood flow response to acetylcholine when compared to placebo

次要结局

  • Forearm blood flow response to sodium nitropusside(During sodium nitropusside infusion 170-190 min after first tea/placebo intake)
  • Forearm blood flow response to L-NMMA(During L-NMMA infusion 220-240 min after first tea/placebo intake)

研究者

发起方
Unilever R&D
申办方类型
Industry
责任方
Sponsor

相似试验