Processed Meat and Colon Carcinogenesis (Hemcancer)

December 13, 2012 updated by: Nathalie Meunier, Institut National de la Recherche Agronomique

Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies

Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

18 healthy volunteers will be randomized and will start the study. The study will last 4 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63009
        • Centre de Recherche en Nutrition Humaine d'Auvergne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Body mass index 20 <= BMI <= 30 kg/m2
  • Affiliated to French National Health Insurance
  • Subject giving his written informed consent
  • Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

  • Positive serologies to HIV or HCV, determined on blood samples
  • Previous medical and/or surgery judged by the investigator as incompatible with this study
  • Previous familial of colon, ovarian or breast cancer
  • Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
  • Dislike ham
  • Heavy consumer of alcohol
  • Practising intensive physical exercise
  • Being under someone's supervision
  • Refusal to be registered on the National Volunteers Data file
  • Dietary habits unreliable to controlled food intake
  • Being in exclusion on the National Volunteers Data file

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ham
Other: Ham
Ham : 180 g per day during 4 days
Experimental: Ham + calcium
Other: Ham + calcium
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
Experimental: Ham + vitamin E
Other: Ham + vitamin E
Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period
Time Frame: Twice a week, before and after every 4 days of interventional period
Twice a week, before and after every 4 days of interventional period

Secondary Outcome Measures

Outcome Measure
Time Frame
Fecal biomarkers
Time Frame: twice a week, before and after every 4 days of interventional period
twice a week, before and after every 4 days of interventional period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Recherche Agronomique

Collaborators

Centre de Recherche en Nutrition Humaine d'Auvergne

Investigators

  • Principal Investigator: Noel CANO, Md, Phd, University Hospital, Clermont-Ferrand
  • Study Director: Fabrice Pierre, PhD, Institut National de la Recherche Agronomique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU794
  • IDRCB 2009-A00322-55 (Registry Identifier: Afssaps)
  • 04/2009 FPIERRE (Other Identifier: CRNH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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