NCT01360320

Brief Summary

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,001

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

21 active sites

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

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

7.5 years

First QC Date

May 23, 2011

Last Update Submit

September 18, 2019

Conditions

Colorectal Serrated AdenomasColorectal Tubular AdenomasColorectal Villous AdenomasColorectal Tubulovillous Adenomas

Keywords

Green teapolyphenolcatechinEGCGEpigallocatechin gallatecolorectal adenomaadenoma preventioncolon cancer prevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy

    3 years

Secondary Outcomes (9)

  • Occurrences of colorectal adenomas or mucosal lesions

    3 years

  • Number of colorectal adenomas or mucosal lesions

    3 years

  • Size of colorectal adenomas or mucosal lesions

    3 years

  • Localization of colorectal adenomas or mucosal lesions

    3 years

  • Histological subtypes of colorectal adenomas or mucosal lesions

    3 years

  • +4 more secondary outcomes

Study Arms (2)

Green tea extract

EXPERIMENTAL

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years

Dietary Supplement: Green tea extract of Camellia Sinensis

Placebo

PLACEBO COMPARATOR

Placebo, packed in hard gelatine capsules, bid for 3 years

Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo

Interventions

Green tea extract of Camellia SinensisDIETARY_SUPPLEMENT

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG * Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks * 150mg EGCG two times daily (p.o.) over the course of three years. * Colonoscopy after 3 years

Green tea extract
Green tea extract of Camellia Sinensis followed by placeboDIETARY_SUPPLEMENT

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG * Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks * Placebo two times daily (p.o.) over the course of three years * Colonoscopy after 3 years

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 50-80 years of age
  • Histologically confirmed colorectal adenomas or serrated lesions removed during colonoscopy within the last 6 months
  • Good performance status (ECOG \< 2) at study entrance
  • Written informed consent.

You may not qualify if:

  • History of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP)
  • History of colon or rectal cancer, other concomitant cancers with the exemption of basalioma or curative treated cancers without actual anticancer medication.
  • Intestinal malabsorption, short bowel syndrome or surgical bowel interventions leading to malabsorption
  • Liver failure (hepatitis, cirrhosis, elevation of liver enzymes ALT, AST or bilirubin to more than 2.5 fold of the reference levels)
  • Inflammatory bowel disease
  • Regular intake of NSAIDs (also Cox2 inhibitors) for more than 3 months per year except of low-dose aspirin (100 mg per day)
  • Immunosuppressive medication
  • Impaired capacity to consent or who are impaired in swallowing a pill
  • Regular consumption of green tea extract as nutritional supplement (with a content of EGCG of more than 100mg per day) of longer than 6 months during the past two years
  • Allergic reactions towards green tea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber

Aalen, 73430, Germany

Location

Klinikum Altenburger Land, Gastroenterologie

Altenburg, 04600, Germany

Location

Klinikum Augsburg, III. Med. Klinik

Augsburg, 86156, Germany

Location

Krankenhaus Bietigheim-Bissingen, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie

Bietigheim-Bissingen, 74321, Germany

Location

Krankenhaus Buchholz, Abteilung Innere Medizin

Buchholz, 21244, Germany

Location

Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide -Medizinische Klinik-

Cologne, Germany

Location

Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie

Esslingen am Neckar, 73730, Germany

Location

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A

Greifswald, 17475, Germany

Location

Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie

Halle, 06108, Germany

Location

Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik

Halle, 06108, Germany

Location

Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie

Halle, 06110, Germany

Location

Universitätsklinikum Halle, Klinik für Innere Medizin I

Halle, 06120, Germany

Location

Klinikum Ludwigsburg, Medizinische Klinik I

Ludwigsburg, 71640, Germany

Location

Diakoniekrankenhaus Mannheim, Medizinische Klinik II

Mannheim, 68163, Germany

Location

II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Klinik Mühldorf Abt.Gastroenterologie

Mühldorf, 84453, Germany

Location

Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik

München, 81525, Germany

Location

Regio Kliniken Pinneberg

Pinneberg, 25421, Germany

Location

Klinikum St. Elisabeth, I. Medizinische Klinik

Straubing, 94315, Germany

Location

Universitätsklinikum Ulm, Klinik für Innere Medizin I

Ulm, 89081, Germany

Location

Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin

Wesel, 46485, Germany

Location

Related Publications (4)

  • 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: 21851602BACKGROUND

  • Melzer A, Sturm N, Rohlmann F, Muche R, Stingl J, Ettrich TJ, Seufferlein T. Interest in complementary and alternative medicine among participants in a study on cancer prevention by green tea extract - results from an expert-based survey of MIRACLE trial participants. BMC Complement Med Ther. 2025 Oct 2;25(1):350. doi: 10.1186/s12906-025-05087-3.

    PMID: 41039315DERIVED

  • Seufferlein T, Ettrich TJ, Menzler S, Messmann H, Kleber G, Zipprich A, Frank-Gleich S, Algul H, Metter K, Odemar F, Heuer T, Hugle U, Behrens R, Berger AW, Scholl C, Schneider KL, Perkhofer L, Rohlmann F, Muche R, Stingl JC. Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial. Am J Gastroenterol. 2022 Jun 1;117(6):884-894. doi: 10.14309/ajg.0000000000001706. Epub 2022 Feb 25.

    PMID: 35213393DERIVED

  • Scholl C, Lepper A, Lehr T, Hanke N, Schneider KL, Brockmoller J, Seufferlein T, Stingl JC. Population nutrikinetics of green tea extract. PLoS One. 2018 Feb 21;13(2):e0193074. doi: 10.1371/journal.pone.0193074. eCollection 2018.

    PMID: 29466429DERIVED

Related Links

Study Officials

  • Julia Stingl, Prof.Dr.med

    Federal Institute for Drugs and Medical Devices, Bonn, Germany

    STUDY CHAIR

  • Thomas Seufferlein, Prof.Dr.med.

    University Hospital Ulm, Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

DE(21)