Clinical trial NCT01254110: Amino Acid and Intestinal Protein Metabolism : Working Study
Official title: Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transduction Pathway
Proteinic Synthesis
Proteolytic System
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

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.


Eligibility 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

Primary outcomes:
measure: assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy
timeFrame: 18 months
Secondary outcomes:
measure: Assessment of involved signaling pathways
timeFrame: 18 months
measure: Assessment of intestinal proteolysis
timeFrame: 18 months
measure: Assessment of protein synthesis rate in intestinal mitochondria
timeFrame: 18 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre d'Investigation Clinique - Hôpital charles Nicolle
state: Seine maritime
Study officials:
affiliation: UH Rouen
name: Moise COEFFIER
role: STUDY_CHAIR
affiliation: UH Rouen
name: Anne-Françoise CAILLEUX, Doctor
role: STUDY_CHAIR
References:
citation: Goichon A, Bertrand J, Chan P, Lecleire S, Coquard A, Cailleux AF, Vaudry D, Dechelotte P, Coeffier M. Enteral delivery of proteins enhances the expression of proteins involved in the cytoskeleton and protein biosynthesis in human duodenal mucosa. Am J Clin Nutr. 2015 Aug;102(2):359-67. doi: 10.3945/ajcn.114.104216. Epub 2015 Jun 24.
citation: Bertrand J, Goichon A, Chan P, Azhar S, Lecleire S, Donnadieu N, Vaudry D, Cailleux AF, Dechelotte P, Coeffier M. Enteral glutamine infusion modulates ubiquitination of heat shock proteins, Grp-75 and Apg-2, in the human duodenal mucosa. Amino Acids. 2014 Apr;46(4):1059-67. doi: 10.1007/s00726-014-1670-x. Epub 2014 Jan 22.
citation: Coeffier M, Claeyssens S, Bole-Feysot C, Guerin C, Maurer B, Lecleire S, Lavoinne A, Donnadieu N, Cailleux AF, Dechelotte P. Enteral delivery of proteins stimulates protein synthesis in human duodenal mucosa in the fed state through a mammalian target of rapamycin-independent pathway. Am J Clin Nutr. 2013 Feb;97(2):286-94. doi: 10.3945/ajcn.112.046946. Epub 2013 Jan 2.
citation: Coeffier M, Claeyssens S, Bensifi M, Lecleire S, Boukhettala N, Maurer B, Donnadieu N, Lavoinne A, Cailleux AF, Dechelotte P. Influence of leucine on protein metabolism, phosphokinase expression, and cell proliferation in human duodenum1,3. Am J Clin Nutr. 2011 Jun;93(6):1255-62. doi: 10.3945/ajcn.111.013649. Epub 2011 Apr 20.