NCT02321969

Brief Summary

Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of this study is to determine the preventive effect of GTE supplements on metachronous colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

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

August 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

4.8 years

First QC Date

December 17, 2014

Last Update Submit

October 26, 2015

Conditions

Neoplasms, Colorectal

Keywords

ChemopreventionColorectal adenomatous polypGreen tea extract

Outcome Measures

Primary Outcomes (1)

  • Recurrence/Number/Size of metachronous colorectal adenoma(s)

    1 year

Secondary Outcomes (4)

  • Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)

    1 year

  • Change of lipid profiles after green tea extract (GTE) supplementation

    1 year

  • Change of body weight, BMI and waist circumference

    1 year

  • Adverse effect(s) of GTE supplementation

    every 1-3 months till the end of study protocol (12 months)

Study Arms (2)

Control

NO INTERVENTION

Without green tea extract (GTE) supplementation

GTE group

EXPERIMENTAL

GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps

Dietary Supplement: GTE (green tea extract)

Interventions

GTE (green tea extract)DIETARY_SUPPLEMENT

6 GTE tablets per day. Daily dose is equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day epigallocatechin gallate \[EGCG\]).

GTE group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- subjects who present one or more adenomatous polyps on colonoscopy.

You may not qualify if:

  • subjects who denied to participate in this study
  • subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease
  • subjects who received partial or total colectomy due to colon cancer or other colonic diseases.
  • subjects who are pregnant
  • subjects who are on aspirin or NSAIDS for any reasons
  • subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason
  • subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Shimizu M, Fukutomi Y, Ninomiya M, Nagura K, Kato T, Araki H, Suganuma M, Fujiki H, Moriwaki H. Green tea extracts for the prevention of metachronous colorectal adenomas: a pilot study. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3020-5. doi: 10.1158/1055-9965.EPI-08-0528.

    PMID: 18990744RESULT

  • Stingl JC, Ettrich T, Muche R, Wiedom M, Brockmoller J, Seeringer A, Seufferlein T. Protocol for minimizing the risk of metachronous adenomas of the colorectum with green tea extract (MIRACLE): a randomised controlled trial of green tea extract versus placebo for nutriprevention of metachronous colon adenomas in the elderly population. BMC Cancer. 2011 Aug 18;11:360. doi: 10.1186/1471-2407-11-360.

    PMID: 21851602RESULT

  • Shin CM, Lee DH, Seo AY, Lee HJ, Kim SB, Son WC, Kim YK, Lee SJ, Park SH, Kim N, Park YS, Yoon H. Green tea extracts for the prevention of metachronous colorectal polyps among patients who underwent endoscopic removal of colorectal adenomas: A randomized clinical trial. Clin Nutr. 2018 Apr;37(2):452-458. doi: 10.1016/j.clnu.2017.01.014. Epub 2017 Jan 29.

    PMID: 28209333DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Tea

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dong Ho Lee, M.D., Ph.D.

    Seoul National Universtiy Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

August 1, 2010

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10