Clinical Trial: Processed Meat and Colon Carcinogenesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Institut National de la Recherche Agronomique

Current Primary Outcome: Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period [ Time Frame: Twice a week, before and after every 4 days of interventional period ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Fecal biomarkers [ Time Frame: twice a week, before and after every 4 days of interventional period ]

Original Secondary Outcome: Same as current

Information By: Institut National de la Recherche Agronomique

Dates:
Date Received: October 9, 2009
Date Started: October 2009
Date Completion:
Last Updated: December 13, 2012
Last Verified: December 2012