Healthy Adult MalesNCT02009917
Non- Essential Amino Acid Requirements and Metabolism in Humans
An observational study of Healthy Adult Males, run by University of British Columbia at 1 site in Canada.
Trial summary
Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Males
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Apr 2015
- Phase
- Observational
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Physiologically Healthy Adult males, 20-40 years of age
Who may be able to join
- 20-40 years of age
- Male
- Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
- Free of any concurrent illness
Who cannot join
- Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
- Men who are classified as underweight(<18.5kg/m2), overweight(25-30kg/m2) or obese (>30kg/m2) using the BMI classification)
- Men who are allergic to milk, eggs and egg protein
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child and Family Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Application of Indicator Amino Acid Oxidation Technique to Determine Non-essential Amino Acids/Nitrogen Requirements in Adult Humans
Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique.
The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.
- Conditions
- Healthy Adult Males
- Keywords
- Indicator Amino Acid Oxidation, Non essential Amino acids, Protein, Amino acid
What is being measured
The primary outcome is the main question the study is designed to answer.
13 Carbon dioxide production
Urine and breath samples will be collected to measure the rate of oxidation of expired breath and flux by enrichment of urine.
Measured: 8 hours (1study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionApr 2015
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 Healthy Adult MalesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009917
- Sponsor's protocol ID
- H12-01683
- Status last verified
- Jul 2017
- First submitted
- 9 Dec 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooper L, Ball RO, Pencharz PB, Sakai R, Elango R. Dispensable Amino Acids, except Glutamine and Proline, Are Ideal Nitrogen Sources for Protein Synthesis in the Presence of Adequate Indispensable Amino Acids in Adult Men. J Nutr. 2020 Sep 1;150(9):2398-2404. doi: 10.1093/jn/nxaa180.
PubMed 32879983
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Indicator Amino Acid Oxidation Technique to Determine Non-essential Amino Acids/Nitrogen Requirements in Adult Humans
- ClinicalTrials.gov ID
- NCT02009917
- Acronym / sponsor ID
- H12-01683
- Conditions
- Healthy Adult Males
- Keywords
- Indicator Amino Acid Oxidation, Non essential Amino acids, Protein, Amino acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Dec 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.
Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique.
The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Physiologically Healthy Adult males, 20-40 years of age
Key inclusion criteria (4 listed)
- 20-40 years of age
- Male
- Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
- Free of any concurrent illness
Key exclusion criteria (3 listed)
- Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
- Men who are classified as underweight(<18.5kg/m2), overweight(25-30kg/m2) or obese (>30kg/m2) using the BMI classification)
- Men who are allergic to milk, eggs and egg protein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
13 Carbon dioxide production
Time frame: 8 hours (1study day)
Urine and breath samples will be collected to measure the rate of oxidation of expired breath and flux by enrichment of urine.
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 18 Jul 2017.
- Derived from this study: PubMed 32879983Cooper L, Ball RO, Pencharz PB, Sakai R, Elango R. Dispensable Amino Acids, except Glutamine and Proline, Are Ideal Nitrogen Sources for Protein Synthesis in the Presence of Adequate Indispensable Amino Acids in Adult Men. J Nutr. 2020 Sep 1;150(9):2398-2404. doi: 10.1093/jn/nxaa180.
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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.
Rajavel Elango, Ph.D principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Males, run by University of British Columbia 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 4 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 18 Jul 2017. 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?
13 Carbon dioxide production (time frame: 8 hours (1study day)). 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 NCT02009917, 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 18 Jul 2017.