Clinical Trial: Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

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

Official Title: Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

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 Summary: 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.
Sponsor: Institut National de la Recherche Agronomique

Current Primary Outcome: Fecal marker [ Time Frame: 12 weeks ]

TBARS Fecal for red meat pane and NOCs Fecal for ham


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NOC [ Time Frame: 12 weeks ]
    Fecal marker for red meat pane
  • cytotoxic activity of fecal water [ Time Frame: 12 weeks ]
    Fecal marker for red meat pane
  • DHN-MA [ Time Frame: 12 weeks ]
    urinary marker for red meat pane
  • TBARs [ Time Frame: 12 weeks ]
    Fecal marker for ham
  • cytotoxic activity of fecal water [ Time Frame: 12 weeks ]
    Fecal marker for ham
  • DHN-MA [ Time Frame: 12 weeks ]
    urinary marker for ham


Original Secondary Outcome: Same as current

Information By: Institut National de la Recherche Agronomique

Dates:
Date Received: June 12, 2015
Date Started: April 2014
Date Completion:
Last Updated: June 12, 2015
Last Verified: June 2015