Green Tea Anticancer Mechanisms in Smokers

Cancer Clinical Trial

Official title:

Green Tea Anticancer Mechanisms in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162642
• Other study ID #: 2007C0109
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: April 20, 2015
• Start date: June 2010
• Est. completion date: August 2013

Study information

• Verified date: April 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• Green Tea
Green Tea 4 cups daily

Other:
• Placebo
4 cups placebo tea for 6 weeks

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Philip Diaz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antioxidant effects of green tea versus placebo consumption.	Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.	Measured at post treatment	No
Secondary	Non-antioxidant, cancer-relevant effects of green tea consumption	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.	Measured at pre-treatment and post treatment	No