Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
40 Years
75 Years
Male
Colorectal Cancer
Trial Information
Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Outcome Measure:
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period
Outcome Time Frame:
Twice a week, before and after every 4 days of interventional period
Safety Issue:
No
Principal Investigator
Noël Cano, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
AU794
NCT ID:
NCT00994526
Start Date:
October 2009
Completion Date:
January 2010
Related Keywords:
- Colorectal Cancer
- Colorectal cancer
- Processed meat
- Calcium
- Vitamin E
- Preventive strategies
- Colorectal Neoplasms
Name | Location |
|---|
