Processed Meat and Colon Carcinogenesis (Hemcancer)
This study has been completed.
Sponsor:
Institut National de la Recherche Agronomique
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
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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:
Drug Information available for:
alpha-Tocopherol
Calcium Gluconate
Tocopherol
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
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
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
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Calcium, Dietary Vitamin E |
Alpha-Tocopherol Tocopherols Tocotrienols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013