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临床试验/NCT01162642
NCT01162642已完成不适用

Green Tea Anticancer Mechanisms in Smokers

Philip Diaz2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Antioxidant effects of green tea versus placebo consumption.

研究概览

简要总结

The purpose of this study is to determine whether green tea may lower the risk of certain cancers.

详细描述

Green tea contains phytochemicals, especially flavonoids. Phytochemicals are not absolutely required for normal functions, but may confer health benefits such as antioxidant actions. One can live without phytochemicals, but one may live longer and better with them. The phytochemicals in tea have been proposed to inhibit cancer onset via several different mechanisms. An obvious question is: Can anti-cancer actions of green tea be duplicated by black tea, which in the USA, is consumed more than green tea? The question remains unanswered, and will not be addressed by this project since many questions about green tea have not been answered yet. The contents of both type teas overlap in flavonoids, but green tea has more of the agents thought to be most effective. For example, some of the research cited below uses the flavonoid epigallocatechin gallate. Green tea has 5 times more of this flavonoid than black tea.

This study has two purposes. First, a case will be made that green tea may have several anti-cancer mechanisms, but this contention is not well confirmed by human intervention studies. This case will be made by addressing four questions. Second, justification will be given for the choice of mechanisms to be examined in this project's human intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
23 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy 23-40 year old males and non-pregnant females, who are moderately heavy smokers (1-1.75 packs/day, > 2 years)

排除标准

  • Habitual tea intake
  • Habitual flavonoid supplementation
  • Soy product intake over twice a week (soy is high in flavonoids).
  • Pulmonary diseases
  • Chronic or acute infection
  • Admission of heavy alcohol intake (> 14 beers or drinks a week)
  • Body mass index (BMI) > 30 (moderately overweight subjects will be taken)
  • Abnormal EKG
  • History of heart or other major health problems (ie arthritis, diabetes).
  • Subjects with slightly high blood pressure will be eligible for the project, but more severe hypertension (>150/100)

结局指标

主要结局

Antioxidant effects of green tea versus placebo consumption.

时间窗: Measured at post treatment

Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.

次要结局

  • Non-antioxidant, cancer-relevant effects of green tea consumption(Measured at pre-treatment and post treatment)

研究者

发起方
Philip Diaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philip Diaz

M.D.

Ohio State University

研究点 (2)

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