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Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer

Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02321969
Enrollment
176
Registered
2014-12-22
Start date
2010-08-31
Completion date
2015-10-31
Last updated
2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Colorectal

Keywords

Chemoprevention, Colorectal adenomatous polyp, Green tea extract

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).

Detailed description

The subjects who had undergone complete removal of colorectal adenomas by endoscopic polypectomy have been enrolled since June 2010. They were then randomized into two groups as follows: supplementation group (0.9 g GTE per day for 12 months) or control group without GTE supplementation. Follow-up colonoscopy was conducted in 12 months. A structured 72-h recall at baseline and the 1-year follow-up was used to assess dietary factors, and to evaluate rectal mucosal proliferation index (RMPI) using known proliferation markers (Ki-67/PCNA), at least 2 random biopsies of rectal mucosa were taken. A sample size of 176 patients (88 per each group) was calculated to give the study 80% power to detect a difference, assuming a two-sided significance test at the 0.05 level.

Interventions

DIETARY_SUPPLEMENTGTE (green tea extract)

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 \[EGCG\]).

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Recurrence/Number/Size of metachronous colorectal adenoma(s)1 year

Secondary

MeasureTime frame
Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)1 year
Change of lipid profiles after green tea extract (GTE) supplementation1 year
Change of body weight, BMI and waist circumference1 year
Adverse effect(s) of GTE supplementationevery 1-3 months till the end of study protocol (12 months)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026