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Completed

NCT Number: NCT02321969

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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]).

Primary outcomes

  1. Recurrence/Number/Size of metachronous colorectal adenoma(s)

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

  3. Change of body weight, BMI and waist circumference

    Time frame: 1 year

  4. Adverse effect(s) of GTE supplementation

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Oct 28, 2015

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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