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Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies

40 Years
75 Years
Not Enrolling
Colorectal Cancer

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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

- 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:


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:


Principal Investigator

Noël Cano, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Clermont-Ferrand


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2009

Completion Date:

January 2010

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Processed meat
  • Calcium
  • Vitamin E
  • Preventive strategies
  • Colorectal Neoplasms