High Tea Consumption on Smoking Related Oxidative Stress | NCT02719860

Studies
High Tea Consumption on Smoking Related Oxidative Stress

NCT02719860

Sponsor

University of Arizona

Status

Completed

Last Update Posted

Mar 25, 2016Estimated

Enrollment

154Actual

Phase

Phase 2

Conditions

Lung Cancer Prevention

Interventions

Green tea
Black tea
Placebo tea

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Mar 8, 2016

First Submission Date that Met QC Criteria

Mar 24, 2016

First Posted Date

Mar 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Name	Class
United States Department of Defense	FED

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Label	Type	Intervention Names
Green tea	Experimental	Dietary Supplement: Green tea
Black tea	Experimental	Dietary Supplement: Black tea
Placebo tea	Placebo Comparator	Dietary Supplement: Placebo tea

Name	Type	Description	Arm Group Labels	Other Names
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	Green tea

Measure	Description	Time Frame
Post-intervention change in urinary 8-hydroxydeoxyguanosine		Baseline and 6 months
Post-intervention change in urinary 8-F2-isoprostanes		Baseline and 6 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages