Healthy MalesPhase 1NCT01032616
Uptake and Utilization of Amino Acids by Splanchnic Bed
A Phase 1 study testing Threonine Experimental: Study Period 1 and Lysine Experimental: Study Period 2 in people with Healthy Males, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- Threonine Experimental: Study Period 1 and Lysine Experimental: Study Period 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Aug 2010
- Phase
- Phase 1
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males
Who cannot join
- History of inborn error of metabolism
- Presence of a chronic disease
- Have unusual dietary practices
- Has recently lost weight
- Receiving pharmacological therapy or hormonal treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed
Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids.
This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.
Read the detailed description
We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.
- Conditions
- Healthy Males
- Being tested
- Threonine Experimental: Study Period 1, Lysine Experimental: Study Period 2
- Keywords
- splanchnic bed, theronine and lysine metabolism uptake, isotopes, metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threonine Experimental: Study Period 1Other
Also called Tracer Isotope - L-[1-13C]threonine
Enteral and parenteral infusion of threonine isotope
Lysine Experimental: Study Period 2Other
Also called Tracer isotope - L-[1-13C]lysine
Both intravenous (iv) and intragastric (ig) Lysine isotopes.
| Study group | Role | What they receive |
|---|---|---|
| Study Period 1 | Experimental | AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences Receives: Other: Threonine Experimental: Study Period 1 |
| Study Period 2 | Experimental | AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences Receives: Other: Lysine Experimental: Study Period 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath VCO2
Measured: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
Blood CO2
Measured: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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, Karen Chapman, The Hospital for Sick Children
- Investigators
- Paul Pencharz, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032616
- Sponsor's protocol ID
- 0019880597 (Part b)
- Status last verified
- Aug 2013
- First submitted
- 11 Dec 2009
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Difference in Uptake and Utilization of Two Amino Acids by the Splanchnic Bed
- ClinicalTrials.gov ID
- NCT01032616
- Acronym / sponsor ID
- 0019880597 (Part b)
- Conditions
- Healthy Males
- Keywords
- splanchnic bed, theronine and lysine metabolism uptake, isotopes, metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Dec 2009 (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.
Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids.
This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.
Detailed description
We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Period 1 | Experimental | Other: Threonine Experimental: Study Period 1AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences |
| Study Period 2 | Experimental | Other: Lysine Experimental: Study Period 2AA given by parenteral and enteral routes with tracer 1-13C phenylalanine given to observe differences |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Males
Key exclusion criteria (5 listed)
- History of inborn error of metabolism
- Presence of a chronic disease
- Have unusual dietary practices
- Has recently lost weight
- Receiving pharmacological therapy or hormonal treatment
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 |
|---|---|---|
| Threonine Experimental: Study Period 1Also: Tracer Isotope - L-[1-13C]threonineEnteral and parenteral infusion of threonine isotope | Other | Study Period 1 |
| Lysine Experimental: Study Period 2Also: Tracer isotope - L-[1-13C]lysineBoth intravenous (iv) and intragastric (ig) Lysine isotopes. | Other | Study Period 2 |
Primary outcome
Breath VCO2
Time frame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
Blood CO2
Time frame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs
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 5 Aug 2013.
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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 Phase 1 study testing Threonine Experimental: Study Period 1 and Lysine Experimental: Study Period 2 in people with Healthy Males, 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 1 inclusion and 5 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 5 Aug 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Breath VCO2 (time frame: -30min, -20min, -10min, +2.5hrs, +3 hrs, +3.5hrs, +4hrs,+4.5hrs, +5hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2013.