Arginine Synthesis in Healthy Adult Humans
1 other identifier
interventional
6
1 country
1
Brief Summary
Arginine synthesis in mammals is a complex process involving at least 8 enzymes and intracellular and interorgan transfer of substrates. The investigators have shown in our neonatal studies that there is no conversion of glutamate to arginine but proline label appears in ornithine, citrulline and arginine. It is clear therefore that arginine is synthesized in human neonates from proline. In adults the source of the carbon backbone is less clear.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2007
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
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 31, 2013
CompletedJanuary 9, 2018
January 1, 2018
9 months
July 26, 2013
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Isotope Levels
8 hours
Study Arms (3)
Test Study 1: 2-15N glutamine
ACTIVE COMPARATORTo determine the contributions make by glutamine to the provision of nitrogen for ornithine, citrulline and arginine syntesis in adults.
Test Study 2: 15N2 arginine &15N proline
ACTIVE COMPARATORadministration of 15N2 arginine \&15N proline to measure arginine and proline flux
Study Test 3: 1-13C glutamine
ACTIVE COMPARATORto determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults.
Interventions
Arginine and Proline isotope tracers
Eligibility Criteria
You may qualify if:
- men of average weight 80 kg will be studied
- healthy, with no know disease of liver, and/or kidney
- weight stable
You may not qualify if:
- weith loss or gain over the last three months
- on medications known to affect amino acid metabolism
- known liver, kidney disease condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
Related Publications (1)
Tomlinson C, Rafii M, Ball RO, Pencharz PB. Arginine can be synthesized from enteral proline in healthy adult humans. J Nutr. 2011 Aug;141(8):1432-6. doi: 10.3945/jn.110.137224. Epub 2011 Jun 15.
PMID: 21677074RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Pencharz, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emeritus Scientist
Study Record Dates
First Submitted
July 26, 2013
First Posted
July 31, 2013
Study Start
September 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 9, 2018
Record last verified: 2018-01