High Tea Consumption on Smoking Related Oxidative Stress
NCT ID: NCT02719860
Last Updated: 2016-03-25
Study Results
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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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2003-09-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Green tea
Green tea
4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Black tea
Black tea
4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Placebo tea
Placebo tea
4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Interventions
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Green tea
4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Black tea
4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Placebo tea
4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Eligibility Criteria
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Inclusion Criteria
* No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
* Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
* Not be pregnant or intending to get pregnant during the study period (women participants).
* Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
* Willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months)
* Willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months).
* Subjects cannot take mega-doses of vitamins during the trial. This is defined as more than 400 IU of vitamin E, 200 ug of selenium, or 1 gm of vitamin C per day, or more than the tolerable upper limits of any other supplement as defined in the Dietary Reference Intake panels developed by the Food and Nutrition Board under the Institute of Medicine. Such vitamin therapy must be discontinued at least 2 weeks prior to study entry.
Exclusion Criteria
* Serious concurrent illness that could interfere with study regimen.
* Subjects with a history of invasive cancer within the past 5 years.
* Subjects who are drinking more than 5 cups of non-herbal tea per week.
* Subjects who cannot or are unwilling to consume caffeinated beverages.
* Subjects unable to perform forced expiratory maneuver during spirometry testing.
* More than one acute emphysema exacerbation within the last 6 month -period .
* Subjects on oxygen.
* Women with positive urinary pregnancy test.
40 Years
80 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Arizona
OTHER
Responsible Party
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Other Identifiers
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03-0014
Identifier Type: -
Identifier Source: org_study_id
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