Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Study Overview
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Brief Summary
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Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country. The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation. The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.

Detailed Description
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24 healthy volunteers will be randomized and will start the study. The study will last 12 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 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. 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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Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: ham
* Other: ham + pomegranate extract
* Other: ham + tocopherol
* Other: rare sirloin steak
* Other: marinated rare sirloin steak
* Other: marinated cooked sirloin steak


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: 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 or red meat Heavy consumer of alcohol Practising intensive physical exercise (> 5 hours) 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>160g per day during 4 days | Other: ham<br>* 160g per day during 4 days<br>|
| Experimental: ham + pomegranate extract<br>160g per day during 4 days | Other: ham + pomegranate extract<br>* 160g per day during 4 days<br>|
| Experimental: ham + tocopherol<br>160g per day during 4 days | Other: ham + tocopherol<br>* 160g per day during 4 days<br>|
| Placebo Comparator: rare sirloin steak<br>110g per day during 4 days | Other: rare sirloin steak<br>* 110g per day during 4 days<br>|
| Experimental: marinated rare sirloin steak<br>110g per day during 4 days | Other: marinated rare sirloin steak<br>* 110g per day during 4 days<br>|
| Experimental: marinated cooked sirloin steak<br>110g per day during 4 days | Other: marinated cooked sirloin steak<br>* 110g per day during 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal marker | TBARS Fecal for red meat pane and NOCs Fecal for ham | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOC | Fecal marker for red meat pane | 12 weeks | 
| cytotoxic activity of fecal water | Fecal marker for red meat pane | 12 weeks | 
| DHN-MA | urinary marker for red meat pane | 12 weeks | 
| TBARs | Fecal marker for ham | 12 weeks | 
| cytotoxic activity of fecal water | Fecal marker for ham | 12 weeks | 
| DHN-MA | urinary marker for ham | 12 weeks |