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Completed

NCT Number: NCT02473302

Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CRNH Auvergne

Clermont-Ferrand, Auvergne, 63009, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ham

Other

160g per day during 4 days

ham + pomegranate extract

Other

160g per day during 4 days

ham + tocopherol

Other

160g per day during 4 days

rare sirloin steak

Other

110g per day during 4 days

marinated rare sirloin steak

Other

110g per day during 4 days

marinated cooked sirloin steak

Other

110g per day during 4 days

Primary outcomes

  1. Fecal marker

    Time frame: 12 weeks

    TBARS Fecal for red meat pane and NOCs Fecal for ham

Secondary outcomes

  1. NOC

    Time frame: 12 weeks

    Fecal marker for red meat pane

  2. cytotoxic activity of fecal water

    Time frame: 12 weeks

    Fecal marker for red meat pane

  3. DHN-MA

    Time frame: 12 weeks

    urinary marker for red meat pane

  4. TBARs

    Time frame: 12 weeks

    Fecal marker for ham

  5. cytotoxic activity of fecal water

    Time frame: 12 weeks

    Fecal marker for ham

  6. DHN-MA

    Time frame: 12 weeks

    urinary marker for ham

Sponsors and collaborators

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Other

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 16, 2015
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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