Trials / Completed
CompletedNCT00994526
Processed Meat and Colon Carcinogenesis
Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Academic / Other
- Sex
- Male
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2009-12-01
- Completion
- 2010-01-01
- First posted
- 2009-10-14
- Last updated
- 2012-12-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00994526. Inclusion in this directory is not an endorsement.