Colorectal Cancer
Conditions
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 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.
Interventions
OTHERham
160g per day during 4 days
OTHERham + pomegranate extract
160g per day during 4 days
OTHERham + tocopherol
160g per day during 4 days
OTHERrare sirloin steak
110g per day during 4 days
OTHERmarinated rare sirloin steak
110g per day during 4 days
OTHERmarinated cooked sirloin steak
110g per day during 4 days
Sponsors
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal marker | 12 weeks | TBARS Fecal for red meat pane and NOCs Fecal for ham |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NOC | 12 weeks | Fecal marker for red meat pane |
| cytotoxic activity of fecal water | 12 weeks | Fecal marker for red meat pane |
| DHN-MA | 12 weeks | urinary marker for red meat pane |
| TBARs | 12 weeks | Fecal marker for ham |
Countries
France
Outcome results
None listed