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Processed Meat and Colon Carcinogenesis (Hemcancer)

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ClinicalTrials.gov Identifier: NCT00994526
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by (Responsible Party):
Nathalie Meunier, University Hospital, Clermont-Ferrand

October 9, 2009
October 14, 2009
December 17, 2012
October 2009
December 2009   (Final data collection date for primary outcome measure)
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period [ Time Frame: Twice a week, before and after every 4 days of interventional period ]
Same as current
Complete list of historical versions of study NCT00994526 on ClinicalTrials.gov Archive Site
Fecal biomarkers [ Time Frame: twice a week, before and after every 4 days of interventional period ]
Same as current
Not Provided
Not Provided
 
Processed Meat and Colon Carcinogenesis
Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Colorectal Cancer
  • Other: Ham
    Ham : 180 g per day during 4 days
  • Other: Ham + calcium
    Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
  • Other: Ham + vitamin E
    Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days
  • Placebo Comparator: Ham
    Intervention: Other: Ham
  • Experimental: Ham + calcium
    Intervention: Other: Ham + calcium
  • Experimental: Ham + vitamin E
    Intervention: Other: Ham + vitamin E
Pierre FH, Martin OC, Santarelli RL, Taché S, Naud N, Guéraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and α-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Same as current
January 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
40 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00994526
AU794
IDRCB 2009-A00322-55 ( Registry Identifier: Afssaps )
04/2009 FPIERRE ( Other Identifier: CRNH )
No
Not Provided
Not Provided
Nathalie Meunier, University Hospital, Clermont-Ferrand
Institut National de la Recherche Agronomique
Centre de Recherche en Nutrition Humaine d'Auvergne
Principal Investigator: Noël Cano, MD, PhD University Hospital, Clermont-Ferrand
Study Director: Fabrice Pierre, PhD Institut National de la Recherche Agronomique
Institut National de la Recherche Agronomique
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP