Glutamine and Intestinal Protein Metabolism
Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Apr 2004
Longer than P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 18, 2013
June 1, 2013
September 13, 2005
June 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Impact on protein synthesis rate and proteolytic activities in intestine.
at the end of infusion (hour 5)
Secondary Outcomes (1)
Comparison of protein expression pattern and glutathione synthesis.
at the end of infusion (hour 5)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- smokers
- Allergic and digestive antecedents,
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Rouen
Rouen, 76031, France
Related Publications (1)
Goichon A, Coeffier M, Claeyssens S, Lecleire S, Cailleux AF, Bole-Feysot C, Chan P, Donnadieu N, Lerebours E, Lavoinne A, Boyer O, Vaudry D, Dechelotte P. Effects of an enteral glucose supply on protein synthesis, proteolytic pathways, and proteome in human duodenal mucosa. Am J Clin Nutr. 2011 Sep;94(3):784-94. doi: 10.3945/ajcn.110.009738. Epub 2011 Jul 27.
PMID: 21795435DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Déchelotte, MD, PhD
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
April 1, 2004
Study Completion
June 1, 2008
Last Updated
June 18, 2013
Record last verified: 2013-06