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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2009-A00322-55 | Registry Identifier | Afssaps | |
| 04/2009 FPIERRE | Other Identifier | CRNH |
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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine d'Auvergne | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ham | Placebo Comparator |
| |
| Ham + calcium | Experimental |
| |
| Ham + vitamin E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ham | Other | Ham : 180 g per day during 4 days |
| |
| Ham + calcium |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period | Twice a week, before and after every 4 days of interventional period |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal biomarkers | twice a week, before and after every 4 days of interventional period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noël Cano, MD, PhD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Fabrice Pierre, PhD | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine d'Auvergne | Clermont-Ferrand | 63009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24025632 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C501309 | ATF7IP protein, human |
| D002118 | Calcium |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Other |
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days |
|
| Ham + vitamin E | Other | Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |