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Glutamine and Intestinal Protein Metabolism

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.
ClinicalTrials.gov Identifier: NCT00213551
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated.

Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Glutamine Drug: Glucose Drug: glutamine-antioxidants containing solution Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans
Study Start Date : April 2004
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources




Primary Outcome Measures :
  1. Impact on protein synthesis rate and proteolytic activities in intestine. [ Time Frame: at the end of infusion (hour 5) ]

Secondary Outcome Measures :
  1. Comparison of protein expression pattern and glutathione synthesis. [ Time Frame: at the end of infusion (hour 5) ]


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
Criteria

Inclusion Criteria:

  • Healthy volunteers, male and female, aged between 18 and 50 years, negatives for HIV1, 2 and for HVC and HVB
  • BMI between 20 and 24 kg/m²,
  • giving their written informed consent
  • no-smokers
  • no allergic and digestive antecedents

Exclusion Criteria:

  • smokers
  • Allergic and digestive antecedents,
  • pregnancy

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 ClinicalTrials.gov identifier (NCT number): NCT00213551


Locations
France
University Hospital of Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pierre Déchelotte, MD, PhD University Hospital, Rouen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213551     History of Changes
Other Study ID Numbers: 2003/037/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs