Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Colorectal Cancer Clinical Trial

Official title:

Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473302
• Other study ID #: Securiviande
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: June 12, 2015
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• 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:

• 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 Design

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

Related Conditions & MeSH terms

• Carcinogenesis
• Colorectal Cancer

Intervention

Other:
• ham
160g per day during 4 days
• ham + pomegranate extract
160g per day during 4 days
• ham + tocopherol
160g per day during 4 days
• rare sirloin steak
110g per day during 4 days
• marinated rare sirloin steak
110g per day during 4 days
• marinated cooked sirloin steak
110g per day during 4 days

Locations

Country	Name	City	State
France	CRNH Auvergne	Clermont-Ferrand	Auvergne

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	Fecal marker	TBARS Fecal for red meat pane and NOCs Fecal for ham	12 weeks	No
Secondary	NOC	Fecal marker for red meat pane	12 weeks	No
Secondary	cytotoxic activity of fecal water	Fecal marker for red meat pane	12 weeks	No
Secondary	DHN-MA	urinary marker for red meat pane	12 weeks	No
Secondary	TBARs	Fecal marker for ham	12 weeks	No
Secondary	cytotoxic activity of fecal water	Fecal marker for ham	12 weeks	No
Secondary	DHN-MA	urinary marker for ham	12 weeks	No