HealthyNCT01912235
Arginine Synthesis in Healthy Adult Humans
A study testing 2-15N glutamine, 15N2 arginine and 15N proline and 1-13C glutamine in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2-15N glutamine, 15N2 arginine and 15N proline and 1-13C glutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 5 men of average weight 80 kg will be studied
- healthy, with no know disease of liver, and/or kidney
- weight stable
Who cannot join
- weith loss or gain over the last three months
- on medications known to affect amino acid metabolism
- known liver, kidney disease condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?
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:
- determine the flux of arginine and proline in healthy adult volunteers
- determine and compare the flux of carbon and nitrogen labeled glutamine
- demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.
- the source of the N atoms in ornithine, citrulline and arginine.
- Conditions
- Healthy
- Being tested
- 2-15N glutamine, 15N2 arginine and 15N proline, 1-13C glutamine
- Keywords
- Arginine synthesis, 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-15N glutamineOther
Glutamine with N15 isotope tracer
15N2 arginine and 15N prolineOther
Arginine and Proline isotope tracers
1-13C glutamineOther
Glutamine carbon isotope tracer
| Study group | Role | What they receive |
|---|---|---|
| Test Study 1: 2-15N glutamine | Active comparator | To determine the contributions make by glutamine to the provision of nitrogen for ornithine, citrulline and arginine syntesis in adults. Receives: Other: 2-15N glutamine |
| Test Study 2: 15N2 arginine &15N proline | Active comparator | administration of 15N2 arginine \&15N proline to measure arginine and proline flux Receives: Other: 15N2 arginine and 15N proline |
| Study Test 3: 1-13C glutamine | Active comparator | to determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults. Receives: Other: 1-13C glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Isotope Levels
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Pencharz, The Hospital for Sick Children
- Investigators
- Paul Pencharz, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912235
- Sponsor's protocol ID
- 02/02/2010
- Status last verified
- Jan 2018
- First submitted
- 26 Jul 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?
- ClinicalTrials.gov ID
- NCT01912235
- Acronym / sponsor ID
- 02/02/2010
- Conditions
- Healthy
- Keywords
- Arginine synthesis, 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- determine the flux of arginine and proline in healthy adult volunteers
- determine and compare the flux of carbon and nitrogen labeled glutamine
- demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.
- the source of the N atoms in ornithine, citrulline and arginine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Study 1: 2-15N glutamine | Active comparator | Other: 2-15N glutamineTo 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 comparator | Other: 15N2 arginine and 15N prolineadministration of 15N2 arginine \&15N proline to measure arginine and proline flux |
| Study Test 3: 1-13C glutamine | Active comparator | Other: 1-13C glutamineto determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 5 men of average weight 80 kg will be studied
- healthy, with no know disease of liver, and/or kidney
- weight stable
Key exclusion criteria (3 listed)
- weith loss or gain over the last three months
- on medications known to affect amino acid metabolism
- known liver, kidney disease condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-15N glutamineGlutamine with N15 isotope tracer | Other | Test Study 1: 2-15N glutamine |
| 15N2 arginine and 15N prolineArginine and Proline isotope tracers | Other | Test Study 2: 15N2 arginine &15N proline |
| 1-13C glutamineGlutamine carbon isotope tracer | Other | Study Test 3: 1-13C glutamine |
Primary outcome
Blood Isotope Levels
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Results publication: PubMed 21677074Tomlinson 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Pencharz, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-15N glutamine, 15N2 arginine and 15N proline and 1-13C glutamine in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Isotope Levels (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.