search
Back to results

Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ham
ham + pomegranate extract
ham + tocopherol
rare sirloin steak
marinated rare sirloin steak
marinated cooked sirloin steak
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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:

  • 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 or red meat
  • Heavy consumer of alcohol
  • Practising intensive physical exercise (> 5 hours)
  • 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

Sites / Locations

  • CRNH Auvergne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

ham

ham + pomegranate extract

ham + tocopherol

rare sirloin steak

marinated rare sirloin steak

marinated cooked sirloin steak

Arm Description

160g per day during 4 days

160g per day during 4 days

160g per day during 4 days

110g per day during 4 days

110g per day during 4 days

110g per day during 4 days

Outcomes

Primary Outcome Measures

Fecal marker
TBARS Fecal for red meat pane and NOCs Fecal for ham

Secondary Outcome Measures

NOC
Fecal marker for red meat pane
cytotoxic activity of fecal water
Fecal marker for red meat pane
DHN-MA
urinary marker for red meat pane
TBARs
Fecal marker for ham
cytotoxic activity of fecal water
Fecal marker for ham
DHN-MA
urinary marker for ham

Full Information

First Posted
June 12, 2015
Last Updated
June 12, 2015
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
search

1. Study Identification

Unique Protocol Identification Number
NCT02473302
Brief Title
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Official Title
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country. The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation. The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.
Detailed Description
24 healthy volunteers will be randomized and will start the study. The study will last 12 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 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ham
Arm Type
Placebo Comparator
Arm Description
160g per day during 4 days
Arm Title
ham + pomegranate extract
Arm Type
Experimental
Arm Description
160g per day during 4 days
Arm Title
ham + tocopherol
Arm Type
Experimental
Arm Description
160g per day during 4 days
Arm Title
rare sirloin steak
Arm Type
Placebo Comparator
Arm Description
110g per day during 4 days
Arm Title
marinated rare sirloin steak
Arm Type
Experimental
Arm Description
110g per day during 4 days
Arm Title
marinated cooked sirloin steak
Arm Type
Experimental
Arm Description
110g per day during 4 days
Intervention Type
Other
Intervention Name(s)
ham
Intervention Description
160g per day during 4 days
Intervention Type
Other
Intervention Name(s)
ham + pomegranate extract
Intervention Description
160g per day during 4 days
Intervention Type
Other
Intervention Name(s)
ham + tocopherol
Intervention Description
160g per day during 4 days
Intervention Type
Other
Intervention Name(s)
rare sirloin steak
Intervention Description
110g per day during 4 days
Intervention Type
Other
Intervention Name(s)
marinated rare sirloin steak
Intervention Description
110g per day during 4 days
Intervention Type
Other
Intervention Name(s)
marinated cooked sirloin steak
Intervention Description
110g per day during 4 days
Primary Outcome Measure Information:
Title
Fecal marker
Description
TBARS Fecal for red meat pane and NOCs Fecal for ham
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
NOC
Description
Fecal marker for red meat pane
Time Frame
12 weeks
Title
cytotoxic activity of fecal water
Description
Fecal marker for red meat pane
Time Frame
12 weeks
Title
DHN-MA
Description
urinary marker for red meat pane
Time Frame
12 weeks
Title
TBARs
Description
Fecal marker for ham
Time Frame
12 weeks
Title
cytotoxic activity of fecal water
Description
Fecal marker for ham
Time Frame
12 weeks
Title
DHN-MA
Description
urinary marker for ham
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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 or red meat Heavy consumer of alcohol Practising intensive physical exercise (> 5 hours) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice PIERRE, Phd
Organizational Affiliation
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noel CANO, Md, Phd
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRNH Auvergne
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63009
Country
France

12. IPD Sharing Statement

Learn more about this trial

Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

We'll reach out to this number within 24 hrs