Processed Meat and Colon Carcinogenesis

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Ham; Other: Ham + calcium; Other: Ham + vitamin E

• Registration Number: NCT00994526
• Lead Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ham	Ham	-
Ham + calcium	Ham + calcium	-
Ham + vitamin E	Ham + vitamin E	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Fecal biomarkers	twice a week, before and after every 4 days of interventional period

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine d'Auvergne; 🇫🇷 Clermont Ferrand, France