Increased Metabolic RequirementEarly Phase 1EPNCT02478801
Protein Requirements in Endurance-trained Athlete
A Early Phase 1 study testing amino acids intake in people with Increased Metabolic Requirement and Healthy, run by University of Toronto.
Trial summary
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Increased Metabolic Requirement, Healthy
- What is being tested?
- amino acids intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2016
- Phase
- Early 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male, endurance-trained participants who regularly more than 40 km/week
- Ability to perform the exercise stimulus (20 km run) on metabolic trial.
Who cannot join
- Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use
About this study
Official title: Evaluation of Protein Requirements in Male Endurance Athletes
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.
Read more
Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than RDA based on nitrogen balance data.
Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.
- Conditions
- Increased Metabolic Requirement, Healthy
- Being tested
- amino acids intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acids intakeDietary supplement
amino acids intakes will be varied at 0.2-2.8 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Endurance trained | Experimental | subjects will receive different levels of amino acids intakes varying from 0.2 to 2.8 g/kg/day. Receives: Dietary Supplement: amino acids intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 (carbon dioxide) excretion (μmol/kg/h)
Measured: 4 hours / study day
Secondary outcomes (1)
[13C]phenylalanine oxidation (μmol/kg/h)
Measured: 4 hours/study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionMay 2016
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 Increased Metabolic RequirementStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478801
- Sponsor's protocol ID
- IAAO-E
- Acronym
- EP
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2015
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kato H, Suzuki K, Bannai M, Moore DR. Protein Requirements Are Elevated in Endurance Athletes after Exercise as Determined by the Indicator Amino Acid Oxidation Method. PLoS One. 2016 Jun 20;11(6):e0157406. doi: 10.1371/journal.pone.0157406. eCollection 2016.
PubMed 27322029
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protein Requirements in Male Endurance Athletes
- ClinicalTrials.gov ID
- NCT02478801
- Acronym / sponsor ID
- EP / IAAO-E
- Conditions
- Increased Metabolic Requirement, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jun 2015 (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 requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.
Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than RDA based on nitrogen balance data.
Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endurance trained | Experimental | Dietary Supplement: amino acids intakesubjects will receive different levels of amino acids intakes varying from 0.2 to 2.8 g/kg/day. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, male, endurance-trained participants who regularly more than 40 km/week
- Ability to perform the exercise stimulus (20 km run) on metabolic trial.
Key exclusion criteria (4 listed)
- Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use
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 |
|---|---|---|
| amino acids intakeamino acids intakes will be varied at 0.2-2.8 g/kg/day | Dietary supplement | Endurance trained |
Primary outcome
13CO2 (carbon dioxide) excretion (μmol/kg/h)
Time frame: 4 hours / study day
1 secondary outcome
[13C]phenylalanine oxidation (μmol/kg/h)
Time frame: 4 hours/study day
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 16 Jun 2016.
- Derived from this study: PubMed 27322029Kato H, Suzuki K, Bannai M, Moore DR. Protein Requirements Are Elevated in Endurance Athletes after Exercise as Determined by the Indicator Amino Acid Oxidation Method. PLoS One. 2016 Jun 20;11(6):e0157406. doi: 10.1371/journal.pone.0157406. eCollection 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing amino acids intake in people with Increased Metabolic Requirement and Healthy, run by University of Toronto.
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 2 inclusion and 4 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
13CO2 (carbon dioxide) excretion (μmol/kg/h) (time frame: 4 hours / study 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 NCT02478801, 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 16 Jun 2016.