NCT02473302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

June 12, 2015

Last Update Submit

June 12, 2015

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Fecal marker

    TBARS Fecal for red meat pane and NOCs Fecal for ham

    12 weeks

Secondary Outcomes (6)

  • NOC

    12 weeks

  • cytotoxic activity of fecal water

    12 weeks

  • DHN-MA

    12 weeks

  • TBARs

    12 weeks

  • cytotoxic activity of fecal water

    12 weeks

  • +1 more secondary outcomes

Study Arms (6)

ham

PLACEBO COMPARATOR

160g per day during 4 days

Other: ham

ham + pomegranate extract

EXPERIMENTAL

160g per day during 4 days

Other: ham + pomegranate extract

ham + tocopherol

EXPERIMENTAL

160g per day during 4 days

Other: ham + tocopherol

rare sirloin steak

PLACEBO COMPARATOR

110g per day during 4 days

Other: rare sirloin steak

marinated rare sirloin steak

EXPERIMENTAL

110g per day during 4 days

Other: marinated rare sirloin steak

marinated cooked sirloin steak

EXPERIMENTAL

110g per day during 4 days

Other: marinated cooked sirloin steak

Interventions

hamOTHER

160g per day during 4 days

ham
ham + pomegranate extractOTHER

160g per day during 4 days

ham + pomegranate extract
ham + tocopherolOTHER

160g per day during 4 days

ham + tocopherol
rare sirloin steakOTHER

110g per day during 4 days

rare sirloin steak
marinated rare sirloin steakOTHER

110g per day during 4 days

marinated rare sirloin steak
marinated cooked sirloin steakOTHER

110g per day during 4 days

marinated cooked sirloin steak

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH Auvergne

Clermont-Ferrand, Auvergne, 63009, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ATF7IP protein, humanTocopherols

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Vitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Fabrice PIERRE, Phd

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

    STUDY CHAIR

  • Noel CANO, Md, Phd

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical research assistant

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

FR(1)