NCT01685307

Brief Summary

Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer. This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

March 21, 2012

Last Update Submit

September 11, 2012

Conditions

PhysiologyDigestive TractHeating Process

Keywords

ileal digestibilitymetabolismstable isotopes

Outcome Measures

Primary Outcomes (1)

  • protein digestibility

    From ileal recovery of the ingested tracer during 8 h after the meal

    single measure

Secondary Outcomes (1)

  • nitrogen metabolism

    single measure

Study Arms (2)

intense cooking process

EXPERIMENTAL

Test meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein

Dietary Supplement: Test meal

mild cooking process

EXPERIMENTAL

Test meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N.

Dietary Supplement: Test meal

Interventions

Test mealDIETARY_SUPPLEMENT

test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.

intense cooking processmild cooking process

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • BMI between 18 an 27
  • Age between 18 and 45 years

You may not qualify if:

  • Gastrointestinal or liver pathology
  • Diabetes
  • Pregnancy
  • Vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche sur volontaires

Bobigny, 93, France

RECRUITING

Related Publications (1)

  • Oberli M, Marsset-Baglieri A, Airinei G, Sante-Lhoutellier V, Khodorova N, Remond D, Foucault-Simonin A, Piedcoq J, Tome D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19.

    PMID: 26290008DERIVED

Study Officials

  • Claire Gaudichon, PhD

    INRA AgroParisTech

    STUDY DIRECTOR

Central Study Contacts

Gheorghe Airinei, MD

CONTACT

33 1 48 95 74 30gheorghe.airinei@avc.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager of the HNRC

Study Record Dates

First Submitted

March 21, 2012

First Posted

September 14, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

FR(1)