Green Tea Anticancer Mechanisms in Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01162642
First received: June 23, 2010
Last updated: June 4, 2013
Last verified: June 2013

June 23, 2010
June 4, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
Antioxidant effects of green tea versus placebo consumption. [ Time Frame: Measured at post treatment ] [ Designated as safety issue: No ]
Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.
Examine antioxidant effects of green tea versus placebo. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.
Complete list of historical versions of study NCT01162642 on ClinicalTrials.gov Archive Site
Non-antioxidant, cancer-relevant effects of green tea consumption [ Time Frame: Measured at pre-treatment and post treatment ] [ Designated as safety issue: No ]
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.
Examine non-antioxidant, cancer-relevant effects of green tea [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Green Tea Anticancer Mechanisms in Smokers
Green Tea Anticancer Mechanisms in Smokers

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cancer
  • Dietary Supplement: Green Tea
    Green Tea 4 cups daily
  • Other: Placebo
    4 cups placebo tea for 6 weeks
  • Experimental: Green Tea
    4 cups daily of green tea for 6 weeks
    Intervention: Dietary Supplement: Green Tea
  • Placebo Comparator: No Green Tea
    4 cups daily of placebo tea for 6 weeks
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
23 Years to 40 Years
Yes
Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu
Contact: Catherine Balint 614-366-2761 Catherine.Balint@osumc.edu
United States
 
NCT01162642
2007C0109
No
Philip Diaz, The Ohio State University
Philip Diaz
Not Provided
Principal Investigator: Philip Diaz, M.D. Ohio State University
Ohio State University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP