Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: ham; Other: ham + pomegranate extract; Other: ham + tocopherol; Other: rare sirloin steak; Other: marinated rare sirloin steak; Other: marinated cooked sirloin steak

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63009
      • CRNH Auvergne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: ham; 160g per day during 4 days	Other: ham; 160g per day during 4 days
Experimental: ham + pomegranate extract; 160g per day during 4 days	Other: ham + pomegranate extract; 160g per day during 4 days
Experimental: ham + tocopherol; 160g per day during 4 days	Other: ham + tocopherol; 160g per day during 4 days
Placebo Comparator: rare sirloin steak; 110g per day during 4 days	Other: rare sirloin steak; 110g per day during 4 days
Experimental: marinated rare sirloin steak; 110g per day during 4 days	Other: marinated rare sirloin steak; 110g per day during 4 days
Experimental: marinated cooked sirloin steak; 110g per day during 4 days	Other: marinated cooked sirloin steak; 110g per day during 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal marker	TBARS Fecal for red meat pane and NOCs Fecal for ham	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOC	Fecal marker for red meat pane	12 weeks
cytotoxic activity of fecal water	Fecal marker for red meat pane	12 weeks
DHN-MA	urinary marker for red meat pane	12 weeks
TBARs	Fecal marker for ham	12 weeks
cytotoxic activity of fecal water	Fecal marker for ham	12 weeks
DHN-MA	urinary marker for ham	12 weeks

Collaborators and Investigators

• Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
• Collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne
• Investigators: Principal Investigator: Noel CANO, Md, Phd, University Hospital, Clermont-Ferrand; Study Chair: Fabrice PIERRE, Phd, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Carcinogenesis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Tocotrienols
• Other Study ID Numbers: Securiviande