Processed Meat and Colon Carcinogenesis (Hemcancer)

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

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Ham + vitamin E; Other: Ham + calcium; Other: Ham

Study type: Interventional

Funder types: Other

Identifiers

NCT00994526

AU794

IDRCB 2009-A00322-55 (Registry Identifier)

04/2009 FPIERRE (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 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

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 3 patient groups, including a placebo group

Ham

Placebo Comparator group

Treatment:

Other: Ham

Ham + calcium

Experimental group

Treatment:

Other: Ham + calcium

Ham + vitamin E

Experimental group

Treatment:

Other: Ham + vitamin E