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Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

NCT01360320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2019-09-20

No results posted yet for this study

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.

Conditions

  • Colorectal Serrated Adenomas
  • Colorectal Tubular Adenomas
  • Colorectal Villous Adenomas
  • Colorectal Tubulovillous Adenomas

Interventions

DIETARY_SUPPLEMENT

Green tea extract of Camellia Sinensis

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

DIETARY_SUPPLEMENT

Green tea extract of Camellia Sinensis followed by placebo

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

Sponsors & Collaborators

  • University of Ulm

    collaborator OTHER

  • KKS Netzwerk

    collaborator NETWORK

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Principal Investigators

  • Julia Stingl, Prof.Dr.med · Federal Institute for Drugs and Medical Devices, Bonn, Germany

  • Thomas Seufferlein, Prof.Dr.med. · University Hospital Ulm, Ulm, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2019-05-31
Completion
2019-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360320 on ClinicalTrials.gov