Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: marinated rare sirloin steak; Other: marinated cooked sirloin steak; Other: ham + tocopherol; Other: ham; Other: ham + pomegranate extract; Other: rare sirloin steak

Study type: Interventional

Funder types: Other

Identifiers

NCT02473302

Securiviande

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 6 patient groups, including a placebo group

ham

Placebo Comparator group

Description:

160g per day during 4 days

Treatment:

Other: ham

ham + pomegranate extract

Experimental group

Description:

160g per day during 4 days

Treatment:

Other: ham + pomegranate extract

ham + tocopherol

Experimental group

Description:

160g per day during 4 days

Treatment:

Other: ham + tocopherol

rare sirloin steak

Placebo Comparator group

Description:

110g per day during 4 days

Treatment:

Other: rare sirloin steak

marinated rare sirloin steak

Experimental group

Description:

110g per day during 4 days

Treatment:

Other: marinated rare sirloin steak

marinated cooked sirloin steak

Experimental group

Description:

110g per day during 4 days

Treatment:

Other: marinated cooked sirloin steak