Amino Acid and Intestinal Protein Metabolism : Working Study

Completed

• Conditions: Proteinic Synthesis; Proteolytic System; Transduction Pathway

• Registration Number: NCT01254110
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-09
• Study Start: 2009-04
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-06
• Primary Completion: 2011-01
• Study Completion: 2012-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy	18 months

Secondary Outcome Measures

Name	Time	Method
Assessment of involved signaling pathways	18 months
Assessment of intestinal proteolysis	18 months
Assessment of protein synthesis rate in intestinal mitochondria	18 months

Trial Locations

Locations (1)

Centre d'Investigation Clinique - Hôpital charles Nicolle; 🇫🇷 Rouen, Seine maritime, France