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Completed

NCT Number: NCT01254110

Amino Acid and Intestinal Protein Metabolism : Working Study

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.

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Key information

Conditions

Transduction Pathway Proteinic Synthesis Proteolytic System

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'Investigation Clinique - Hôpital charles Nicolle

Rouen, Seine maritime, 76031, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy

    Time frame: 18 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism

Acronym: Intesmetapro

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 6, 2010
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.