Cancer
Conditions
Keywords
Healthy moderately heavy smokers
Brief summary
The purpose of this study is to determine whether green tea may lower the risk of certain cancers.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTGreen Tea
Green Tea 4 cups daily
OTHERPlacebo
4 cups placebo tea for 6 weeks
Sponsors
Philip Diaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
23 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant effects of green tea versus placebo consumption. | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-antioxidant, cancer-relevant effects of green tea consumption | 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. |
Countries
United States
Outcome results
None listed