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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01254110
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
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.

Condition or disease
Transduction Pathway Proteinic Synthesis Proteolytic System

Study Type : Observational
Actual Enrollment : 36 participants
Time Perspective: Prospective
Official Title: Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism
Study Start Date : April 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2012

Enterally fed with leucine
Enterally fed with glutamine
Enterally fed with protein powder

Primary Outcome Measures :
  1. assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Assessment of involved signaling pathways [ Time Frame: 18 months ]
  2. Assessment of intestinal proteolysis [ Time Frame: 18 months ]
  3. Assessment of protein synthesis rate in intestinal mitochondria [ Time Frame: 18 months ]

Biospecimen Retention:   Samples Without DNA
whole blood duodenal tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01254110

Centre d'Investigation Clinique - Hôpital charles Nicolle
Rouen, Seine maritime, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Study Chair: Moise COEFFIER UH Rouen
Study Chair: Anne-Françoise CAILLEUX, Doctor UH Rouen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Rouen Identifier: NCT01254110     History of Changes
Other Study ID Numbers: 2007/142/HP
ID RCB 2008-A00692-53
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013