Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: ham + pomegranate extract; Other: ham + tocopherol; Other: marinated cooked sirloin steak; Other: ham; Other: rare sirloin steak; Other: marinated rare sirloin steak

• Registration Number: NCT02473302
• Lead Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-06
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-12
• Last Update Submitted: 2015-06-12
• Study First Posted: 2015-06-16
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ham + pomegranate extract	ham + pomegranate extract	160g per day during 4 days
ham + tocopherol	ham + tocopherol	160g per day during 4 days
marinated cooked sirloin steak	marinated cooked sirloin steak	110g per day during 4 days
ham	ham	160g per day during 4 days
rare sirloin steak	rare sirloin steak	110g per day during 4 days
marinated rare sirloin steak	marinated rare sirloin steak	110g per day during 4 days

Primary Outcome Measures

Name	Time	Method
Fecal marker	12 weeks	TBARS Fecal for red meat pane and NOCs Fecal for ham

Secondary Outcome Measures

Name	Time	Method
cytotoxic activity of fecal water	12 weeks	Fecal marker for ham
DHN-MA	12 weeks	urinary marker for ham
NOC	12 weeks	Fecal marker for red meat pane
TBARs	12 weeks	Fecal marker for ham

Trial Locations

Locations (1)

CRNH Auvergne; 🇫🇷 Clermont-Ferrand, Auvergne, France