Glutamine and Intestinal Protein Metabolism

Healthy Volunteers Clinical Trial

Official title:

Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213551
• Other study ID #: 2003/037/HP
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: April 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Glutamine

• Glucose

• glutamine-antioxidants containing solution

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on protein synthesis rate and proteolytic activities in intestine.		at the end of infusion (hour 5)
Secondary	Comparison of protein expression pattern and glutathione synthesis.		at the end of infusion (hour 5)