Clinical trial NCT02473302: Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Official title: Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2015-06-16
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal marker
timeFrame: 12 weeks
Secondary outcomes:
measure: NOC
timeFrame: 12 weeks
measure: cytotoxic activity of fecal water
timeFrame: 12 weeks
measure: DHN-MA
timeFrame: 12 weeks
measure: TBARs
timeFrame: 12 weeks
measure: cytotoxic activity of fecal water
timeFrame: 12 weeks
measure: DHN-MA
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CRNH Auvergne
state: Auvergne
Study officials:
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Fabrice PIERRE, Phd
role: STUDY_CHAIR
affiliation: University Hospital, Clermont-Ferrand
name: Noel CANO, Md, Phd
role: PRINCIPAL_INVESTIGATOR
References: