Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

NCT ID: NCT02473302

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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ham

160g per day during 4 days

Group Type PLACEBO_COMPARATOR

ham

Intervention Type OTHER

160g per day during 4 days

ham + pomegranate extract

160g per day during 4 days

Group Type EXPERIMENTAL

ham + pomegranate extract

Intervention Type OTHER

160g per day during 4 days

ham + tocopherol

160g per day during 4 days

Group Type EXPERIMENTAL

ham + tocopherol

Intervention Type OTHER

160g per day during 4 days

rare sirloin steak

110g per day during 4 days

Group Type PLACEBO_COMPARATOR

rare sirloin steak

Intervention Type OTHER

110g per day during 4 days

marinated rare sirloin steak

110g per day during 4 days

Group Type EXPERIMENTAL

marinated rare sirloin steak

Intervention Type OTHER

110g per day during 4 days

marinated cooked sirloin steak

110g per day during 4 days

Group Type EXPERIMENTAL

marinated cooked sirloin steak

Intervention Type OTHER

110g per day during 4 days

Interventions

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ham

160g per day during 4 days

Intervention Type OTHER

ham + pomegranate extract

160g per day during 4 days

Intervention Type OTHER

ham + tocopherol

160g per day during 4 days

Intervention Type OTHER

rare sirloin steak

110g per day during 4 days

Intervention Type OTHER

marinated rare sirloin steak

110g per day during 4 days

Intervention Type OTHER

marinated cooked sirloin steak

110g per day during 4 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role lead

Responsible Party

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Adeline BLOT

Clinical research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabrice PIERRE, Phd

Role: STUDY_CHAIR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Noel CANO, Md, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CRNH Auvergne

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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Securiviande

Identifier Type: -

Identifier Source: org_study_id

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