Processed Meat and Colon Carcinogenesis (Hemcancer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994526
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : December 17, 2012
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by (Responsible Party):
Nathalie Meunier, University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Ham Other: Ham + calcium Other: Ham + vitamin E Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin E

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Fecal biomarkers [ Time Frame: twice a week, before and after every 4 days of interventional period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994526

Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont Ferrand, France, 63009
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Centre de Recherche en Nutrition Humaine d'Auvergne
Principal Investigator: Noël Cano, MD, PhD University Hospital, Clermont-Ferrand
Study Director: Fabrice Pierre, PhD Institut National de la Recherche Agronomique

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nathalie Meunier, Clinical research Assistant, University Hospital, Clermont-Ferrand Identifier: NCT00994526     History of Changes
Other Study ID Numbers: AU794
IDRCB 2009-A00322-55 ( Registry Identifier: Afssaps )
04/2009 FPIERRE ( Other Identifier: CRNH )
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Nathalie Meunier, University Hospital, Clermont-Ferrand:
Colorectal cancer
Processed meat
Vitamin E
Preventive strategies

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Vitamin E
Calcium, Dietary
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents