Processed Meat and Colon Carcinogenesis (Hemcancer)

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: Colorectal Cancer
• Intervention / Treatment: Other: Ham; Other: Ham + calcium; Other: Ham + vitamin E

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Twice a week, before and after every 4 days of interventional period

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

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: Colorectal cancer; Vitamin E; Calcium; Processed meat; Preventive strategies
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Carcinogenesis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Calcium-Regulating Hormones and Agents; Antioxidants; Calcium; Vitamin E
• Other Study ID Numbers: AU794; IDRCB 2009-A00322-55 (Registry Identifier: Afssaps); 04/2009 FPIERRE (Other Identifier: CRNH)