Processed Meat and Colon Carcinogenesis

Colorectal Cancer Clinical Trial

— Hemcancer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994526
• Other study ID #: AU794
• Secondary ID: IDRCB 2009-A0032
• Status: Completed
• Phase: N/A
• First received: October 9, 2009
• Last updated: December 13, 2012
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: December 2012
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinogenesis
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Ham
Ham : 180 g per day during 4 days
• Ham + calcium
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
• Ham + vitamin E
Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine d'Auvergne	Clermont Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Recherche Agronomique	Centre de Recherche en Nutrition Humaine d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period		Twice a week, before and after every 4 days of interventional period	No
Secondary	Fecal biomarkers		twice a week, before and after every 4 days of interventional period	No

External Links

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