NCT01162642

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

June 23, 2010

Last Update Submit

April 20, 2015

Conditions

Cancer

Keywords

Healthy moderately heavy smokers

Outcome Measures

Primary Outcomes (1)

  • Antioxidant effects of green tea versus placebo consumption.

    Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.

    Measured at post treatment

Secondary Outcomes (1)

  • Non-antioxidant, cancer-relevant effects of green tea consumption

    Measured at pre-treatment and post treatment

Study Arms (2)

Green Tea

EXPERIMENTAL

4 cups daily of green tea for 6 weeks

Dietary Supplement: Green Tea

No Green Tea

PLACEBO COMPARATOR

4 cups daily of placebo tea for 6 weeks

Other: Placebo

Interventions

Green TeaDIETARY_SUPPLEMENT

Green Tea 4 cups daily

Green Tea
PlaceboOTHER

4 cups placebo tea for 6 weeks

No Green Tea

Eligibility Criteria

Age23 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy 23-40 year old males and non-pregnant females, who are moderately heavy smokers (1-1.75 packs/day, \> 2 years)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Philip Diaz, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 23, 2010

First Posted

July 14, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

US(1)