Glutamine and Intestinal Protein Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213551
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Glutamine
Drug: Glucose
Drug: glutamine-antioxidants containing solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

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

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

Estimated Enrollment: 30
Study Start Date: April 2004
Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: NCT00213551     History of Changes
Other Study ID Numbers: 2003/037/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 28, 2014