Glutamine and Intestinal Protein Metabolism

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00213551
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2004
• Actual Study Completion Date: Jun 1, 2008

Outcome Measures

Primary Outcome Measures

1. Impact on protein synthesis rate and proteolytic activities in intestine. [at the end of infusion (hour 5)]

Secondary Outcome Measures

1. Comparison of protein expression pattern and glutathione synthesis. [at the end of infusion (hour 5)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Rouen	Rouen		France	76031

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

• Principal Investigator: Pierre Déchelotte, MD, PhD, University Hospital, Rouen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT00213551
• Other Study ID Numbers: 2003/037/HP
• First Posted: Sep 21, 2005
• Last Update Posted: Jun 18, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Antioxidants

Study Results

No Results Posted as of Jun 18, 2013