Processed Meat and Colon Carcinogenesis (Hemcancer)

This study has been completed.
Sponsor:
Collaborator:
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by (Responsible Party):
Nathalie Meunier, University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00994526
First received: October 9, 2009
Last updated: December 13, 2012
Last verified: December 2012
  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 Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fecal biomarkers [ Time Frame: twice a week, before and after every 4 days of interventional period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Institut National de la Recherche Agronomique

Additional 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, 04/2009 FPIERRE
Study First Received: October 9, 2009
Last Updated: December 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:
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
Alpha-Tocopherol
Tocopherols
Tocotrienols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 15, 2014