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Completed

NCT Number: NCT01162642

Green Tea Anticancer Mechanisms in Smokers

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

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Key information

Conditions

Age range

23 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Green Tea

Dietary Supplement

Green Tea 4 cups daily

Placebo

Other

4 cups placebo tea for 6 weeks

Primary outcomes

  1. Antioxidant effects of green tea versus placebo consumption.

    Time frame: 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.

Secondary outcomes

  1. Non-antioxidant, cancer-relevant effects of green tea consumption

    Time frame: Measured at pre-treatment and post treatment

    Examine non-antioxidant, cancer-relevant effects of green tea by measuring NF-kappaB inducing kinase; phosphorylation of cell signaling agents; tumor necrosis factor gene expression; lysyl oxidase enzyme; blockage of cancer cell proliferation.

Sponsors and collaborators

Lead sponsor

Philip Diaz

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2010
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.