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CompletedNCT01912235Updated Jan 9, 2018

Arginine Synthesis in Healthy Adult Humans

An interventional study of 2-15N glutamine and 15N2 arginine and 15N proline in Healthy, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

Read the detailed description

Through a series of test in healthy adults using tandem mass spectrometry with carbon labeled GLN and nitrogen labeled PRO to determine the dietary source for the carbon chain of ORN, CIT and ARG. Additionally, using Nitrogen labeled GLN, we will identify the source of the nitrogen atoms in these amino acids.

Using guanidino - 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine and 15N Proline we will be able to:

  1. determine the flux of arginine and proline in healthy adult volunteers
  2. determine and compare the flux of carbon and nitrogen labeled glutamine
  3. demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.
  4. the source of the N atoms in ornithine, citrulline and arginine.
02

Conditions studied

  • Healthy

Keywords

  • Arginine synthesis
  • 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline
03

In context

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 5 men of average weight 80 kg will be studied
  • healthy, with no know disease of liver, and/or kidney
  • weight stable

Exclusion criteria

Exclusion Criteria:

  • weith loss or gain over the last three months
  • on medications known to affect amino acid metabolism
  • known liver, kidney disease condition
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Active comparator
    Test Study 1: 2-15N glutamine

    To determine the contributions make by glutamine to the provision of nitrogen for ornithine, citrulline and arginine syntesis in adults.

    Other: 2-15N glutamine

  • Active comparator
    Test Study 2: 15N2 arginine &15N proline

    administration of 15N2 arginine \&15N proline to measure arginine and proline flux

    Other: 15N2 arginine and 15N proline

  • Active comparator
    Study Test 3: 1-13C glutamine

    to determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults.

    Other: 1-13C glutamine

Interventions

  • Other2-15N glutamine

    Glutamine with N15 isotope tracer

  • Other15N2 arginine and 15N proline

    Arginine and Proline isotope tracers

  • Other1-13C glutamine

    Glutamine carbon isotope tracer

06

What researchers measure

Primary outcomes

  1. Blood Isotope Levels

    Time frame: 8 hours

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario, Canada
08

References and documents

Publications

  • 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. PubMed 21677074 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01912235
Lead sponsor
The Hospital for Sick Children
Responsible party
Dr. Paul Pencharz (Emeritus Scientist, The Hospital for Sick Children) — Principal investigator
First posted
Jul 31, 2013
Start date
Sep 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jan 9, 2018

Study contacts

Paul Pencharz, MD
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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