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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01254110
First received: March 9, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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
Transduction Pathway
Proteinic Synthesis
Proteolytic System

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of involved signaling pathways [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Assessment of intestinal proteolysis [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Assessment of protein synthesis rate in intestinal mitochondria [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood duodenal tissue


Enrollment: 36
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Enterally fed with leucine
2
Enterally fed with glutamine
3
Enterally fed with protein powder

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01254110

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

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01254110     History of Changes
Other Study ID Numbers: 2007/142/HP, ID RCB 2008-A00692-53
Study First Received: March 9, 2009
Last Updated: October 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 29, 2014