NCT00994526

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

October 9, 2009

Last Update Submit

December 13, 2012

Conditions

Colorectal Cancer

Keywords

Colorectal cancerProcessed meatCalciumVitamin EPreventive strategies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Fecal biomarkers

    twice a week, before and after every 4 days of interventional period

Study Arms (3)

Ham

PLACEBO COMPARATOR
Other: Ham

Ham + calcium

EXPERIMENTAL
Other: Ham + calcium

Ham + vitamin E

EXPERIMENTAL
Other: Ham + vitamin E

Interventions

HamOTHER

Ham : 180 g per day during 4 days

Ham
Ham + calciumOTHER

Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days

Ham + calcium
Ham + vitamin EOTHER

Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days

Ham + vitamin E

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:

  • Positive serologies to HIV or HCV, determined on blood samples
  • 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
  • Heavy consumer of alcohol
  • Practising intensive physical exercise
  • 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)

Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, 63009, France

Location

Related Publications (1)

  • 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.

    PMID: 24025632DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ATF7IP protein, humanCalciumVitamin E

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • 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

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

October 9, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

FR(1)