Green Tea Anticancer Mechanisms in Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Green Tea

4 cups daily of green tea for 6 weeks

Group Type EXPERIMENTAL

Green Tea

Intervention Type DIETARY_SUPPLEMENT

Green Tea 4 cups daily

No Green Tea

4 cups daily of placebo tea for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

4 cups placebo tea for 6 weeks

Interventions

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Green Tea

Green Tea 4 cups daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 cups placebo tea for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

23 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes