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Processed Meat and Colon Carcinogenesis (Hemcancer)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994526
First Posted: October 14, 2009
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by (Responsible Party):
Nathalie Meunier, University Hospital, Clermont-Ferrand
  Purpose
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.

Condition Intervention
Colorectal Cancer Other: Ham Other: Ham + calcium Other: Ham + vitamin E

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies

Further study details as provided by Nathalie Meunier, University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Fecal biomarkers [ Time Frame: twice a week, before and after every 4 days of interventional period ]

Enrollment: 18
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ham Other: Ham
Ham : 180 g per day during 4 days
Experimental: Ham + calcium Other: Ham + calcium
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
Experimental: Ham + vitamin E Other: Ham + vitamin E
Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994526


Locations
France
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont Ferrand, France, 63009
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Centre de Recherche en Nutrition Humaine d'Auvergne
Investigators
Principal Investigator: Noël Cano, MD, PhD University Hospital, Clermont-Ferrand
Study Director: Fabrice Pierre, PhD Institut National de la Recherche Agronomique
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nathalie Meunier, Clinical research Assistant, University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00994526     History of Changes
Other Study ID Numbers: AU794
IDRCB 2009-A00322-55 ( Registry Identifier: Afssaps )
04/2009 FPIERRE ( Other Identifier: CRNH )
First Submitted: October 9, 2009
First Posted: October 14, 2009
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Nathalie Meunier, University Hospital, Clermont-Ferrand:
Colorectal cancer
Processed meat
Calcium
Vitamin E
Preventive strategies

Additional relevant MeSH terms:
Colorectal Neoplasms
Carcinogenesis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents