Amino Acid and Intestinal Protein Metabolism : Working Study (Intesmetapro)

October 15, 2013 updated by: University Hospital, Rouen

Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism

Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Seine maritime
      • Rouen, Seine maritime, France, 76031
        • Centre d'Investigation Clinique - Hôpital charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers

Description

Inclusion Criteria:

  • volunteers with seronegativity for HIV1 and HIV2 and HCV and HVB
  • good nutritional state with physical indication mass included between 18,5 and 25kg/m2
  • non-smoking volunteers
  • volunteers without digestive, allergic or haemorrhagic history
  • volunteers without progressive disease
  • digestive endoscopy tolerance
  • age >=18 and <= 50years
  • consent obtained from volunteers

Exclusion Criteria:

  • smoking volunteers
  • volunteers with digestive, or allergic history
  • volunteers with haemorrhagic sign
  • pregnancy
  • progressive digestive disease
  • significant progressive disease
  • volunteers with therapeutic treatment (aspirin)
  • digestive endoscopy intolerance
  • volunteers with neurological disorder or with delicate psychological state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Enterally fed with leucine
2
Enterally fed with glutamine
3
Enterally fed with protein powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of involved signaling pathways
Time Frame: 18 months
18 months
Assessment of intestinal proteolysis
Time Frame: 18 months
18 months
Assessment of protein synthesis rate in intestinal mitochondria
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Study Chair: Moise COEFFIER, UH Rouen
  • Study Chair: Anne-Françoise CAILLEUX, Doctor, UH Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2007/142/HP
  • ID RCB 2008-A00692-53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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