Processed Meat and Colon Carcinogenesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Ham
* Other: Ham + calcium
* Other: Ham + vitamin E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Processed meat, Calcium, Vitamin E, Preventive strategies