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临床试验/NCT02735486
NCT02735486已完成不适用

Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease

University of Reading1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Reduction in blood pressure (BP)

研究概览

简要总结

The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.

详细描述

A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Apparently healthy males,
  • •Age (30 - 65) years,
  • •Not diabetic or plasma glucose > 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
  • •Subjects < 10% risk of cardiovascular disease

排除标准

  • •Men younger than 30 years and older that 65 years,
  • •Men who are sick or on anti-diabetic and anti-hypertensive drugs.
  • •Men who have history of heart attack or stroke within the last 12 months
  • •Men who are on lipids lowering drugs

研究组 & 干预措施

Ginger drink

Experimental

Experimental: Ginger drink (300 ml) to be consumed during the study visit

干预措施: Ginger drink (Dietary Supplement)

Placebo: Super pure water

Placebo Comparator

Super Pure water low in nitrate content

干预措施: Placebo: Super pure water (Dietary Supplement)

结局指标

主要结局

Reduction in blood pressure (BP)

时间窗: Six (6) hours

Reduction in blood pressure (BP)

次要结局

  • Flow mediated dilatation(Six (6) hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy Paul Edward Spencer

Professor

University of Reading

研究点 (1)

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