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Completed

NCT Number: NCT02719860

High Tea Consumption on Smoking Related Oxidative Stress

The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

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

Inclusion criteria

  • FEV1 < 85% and at least 25 pack-years of current or former smoking history.
  • 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

  • Subjects immunosuppressed by virtue of medication or disease.
  • 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.

Treatment and study plan

Green Tea

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Primary outcomes

  1. Post-intervention change in urinary 8-hydroxydeoxyguanosine

    Time frame: Baseline and 6 months

  2. Post-intervention change in urinary 8-F2-isoprostanes

    Time frame: Baseline and 6 months

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking Related Oxidative Stress

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

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.

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