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Processed Meat and Colon Carcinogenesis (Hemcancer)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ham
Ham + calcium
Ham + vitamin E
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer focused on measuring Colorectal cancer, Processed meat, Calcium, Vitamin E, Preventive strategies

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Recherche en Nutrition Humaine d'Auvergne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Ham

Ham + calcium

Ham + vitamin E

Arm Description

Outcomes

Primary Outcome Measures

Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period

Secondary Outcome Measures

Fecal biomarkers

Full Information

First Posted
October 9, 2009
Last Updated
December 13, 2012
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT00994526
Brief Title
Processed Meat and Colon Carcinogenesis
Acronym
Hemcancer
Official Title
Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Processed meat, Calcium, Vitamin E, Preventive strategies

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ham
Arm Type
Placebo Comparator
Arm Title
Ham + calcium
Arm Type
Experimental
Arm Title
Ham + vitamin E
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ham
Intervention Description
Ham : 180 g per day during 4 days
Intervention Type
Other
Intervention Name(s)
Ham + calcium
Intervention Description
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
Intervention Type
Other
Intervention Name(s)
Ham + vitamin E
Intervention Description
Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Fecal biomarkers
Time Frame
twice a week, before and after every 4 days of interventional period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noël Cano, MD, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrice Pierre, PhD
Organizational Affiliation
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine d'Auvergne
City
Clermont Ferrand
ZIP/Postal Code
63009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24025632
Citation
Pierre FH, Martin OC, Santarelli RL, Tache S, Naud N, Gueraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and alpha-tocopherol suppress cured-meat promotion of chemically induced colon carcinogenesis in rats and reduce associated biomarkers in human volunteers. Am J Clin Nutr. 2013 Nov;98(5):1255-62. doi: 10.3945/ajcn.113.061069. Epub 2013 Sep 11.
Results Reference
derived
Links:
URL
http://www.inra.fr
Description
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Processed Meat and Colon Carcinogenesis

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