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Processed Meat and Colon Carcinogenesis

NCT ID: NCT00994526

Last Updated: 2012-12-17

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer Processed meat Calcium Vitamin E Preventive strategies

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

Group Type PLACEBO_COMPARATOR

Ham

Intervention Type OTHER

Ham : 180 g per day during 4 days

Ham + calcium

Group Type EXPERIMENTAL

Ham + calcium

Intervention Type OTHER

Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days

Ham + vitamin E

Group Type EXPERIMENTAL

Ham + vitamin E

Intervention Type OTHER

Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days

Interventions

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Ham

Ham : 180 g per day during 4 days

Intervention Type OTHER

Ham + calcium

Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days

Intervention Type OTHER

Ham + vitamin E

Ham : 160g/d during 4 days Vitamin E : 80 mg/d 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

* 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
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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Nathalie Meunier

Clinical research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noël Cano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Fabrice Pierre, PhD

Role: STUDY_DIRECTOR

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

Locations

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Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Pierre FH, Martin OC, Santarelli RL, Tache S, Naud N, Gueraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and alpha-tocopherol suppress cured-meat promotion of chemically induced colon carcinogenesis in rats and reduce associated biomarkers in human volunteers. Am J Clin Nutr. 2013 Nov;98(5):1255-62. doi: 10.3945/ajcn.113.061069. Epub 2013 Sep 11.

Reference Type DERIVED
PMID: 24025632 (View on PubMed)

Related Links

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http://www.inra.fr

Related Info

Other Identifiers

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IDRCB 2009-A00322-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

04/2009 FPIERRE

Identifier Type: OTHER

Identifier Source: secondary_id

AU794

Identifier Type: -

Identifier Source: org_study_id