Clinical trial · Interventional
Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
NCT02321969CI-TRIAL-00019642completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GTE (green tea extract) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Without green tea extract (GTE) supplementation
- type
- EXPERIMENTAL
- label
- GTE group
- description
- GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps
- interventionNames
- Dietary Supplement: GTE (green tea extract)
Primary outcomes (1)
- measure
- Recurrence/Number/Size of metachronous colorectal adenoma(s)
- timeFrame
- 1 year
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTShimizu 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 18990744
- RESULTStingl 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 21851602
- DERIVEDShin 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 28209333