Clinical Trials Directory

Trials / Completed

CompletedNCT02473302

Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Academic / Other
Sex
Male
Age
40 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERham160g per day during 4 days
OTHERham + pomegranate extract160g per day during 4 days
OTHERham + tocopherol160g per day during 4 days
OTHERrare sirloin steak110g per day during 4 days
OTHERmarinated rare sirloin steak110g per day during 4 days
OTHERmarinated cooked sirloin steak110g per day during 4 days

Timeline

Start date
2014-04-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2015-06-16
Last updated
2015-06-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02473302. Inclusion in this directory is not an endorsement.