Increased Metabolic RequirementEA3NCT02874638
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes
A study testing BASE egg protein, BCAA-enriched egg protein and small amount of essential amino acids 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). The biological value of protein depends on its amino acid composition. 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
- Increased Metabolic Requirement, Healthy
- What is being tested?
- BASE egg protein, BCAA-enriched egg protein and small amount of essential amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 31 Dec 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- endurance-trained participants who regularly run more than 40 km/week
- Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold, in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
- Ability to complete the 16-km familiarization run in session 2
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: Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method.
Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).
The biological value of protein depends on its amino acid composition. Essential amino acids are believed to have main role on whole body protein metabolism. However, it remains to be determined what role non-essential amino acids (NEAA) may have in regulating protein metabolism and contributing to the increased protein requirements after endurance exercise.
Read more
The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. However, the IAAO method has never been utilized for assessing the effect of NEAA on protein requirements after endurance exercise.
The objective of the current study is to investigate the importance of NEAA for endurance-trained male subjects.
- Conditions
- Increased Metabolic Requirement, Healthy
- Being tested
- BASE egg protein, BCAA-enriched egg protein, small amount of essential amino acids, large amount of essential amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASE egg proteinDietary supplement
0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
BCAA-enriched egg proteinDietary supplement
BCAA-enriched egg protein provided as crystalline amino acid.
small amount of essential amino acidsDietary supplement
essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein
large amount of essential amino acidsDietary supplement
essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein
| Study group | Role | What they receive |
|---|---|---|
| BASE egg protein | Experimental | 0.8 g/kg/d of BASE protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: BASE egg protein |
| BCAA-enriched egg protein | Experimental | branched-chain amino acid-enriched egg protein Receives: Dietary Supplement: BCAA-enriched egg protein |
| small amount of essential amino acids | Experimental | small amount of essential amino acids made after egg protein, which is equivalent to the amount of essential amino acids in BASE Receives: Dietary Supplement: small amount of essential amino acids |
| large amount of essential amino acids | Experimental | large amount of essential amino acids made after egg protein, which is equivalent to the amount of amino acids in BCAA Receives: Dietary Supplement: large amount of essential amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 (carbon dioxide) excretion rate (μmol/kg/h)
8 hours after exercise followed by ingesting 13C-labelled phenylalanine and one of 5 different amount of amino acids intake, 13CO2 excretion rate is determined by multiplying the enrichment of 13CO2 in breath measured by Mass spectrometry and CO2 production rate measured by metabolic cart.
Measured: at 8 hours after the end of exercise]
Secondary outcomes (1)
[13C]phenylalanine oxidation rate (μmol/kg/h)
8 hours after exercise followed by ingesting 13C-labelled phenylalanine and one of 5 different amount of amino acids intake, 13CO2 excretion rate is determined dividing 13CO2 excretion rate by urinary enrichment of 13C-phenylalanine in breath measured by Mass spectrometry, and CO2 production rate measured by metabolic cart.
Measured: at 8 hours after the end of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 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
- Investigators
- Daniel Moore, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874638
- Sponsor's protocol ID
- IAAO-EA3
- Acronym
- EA3
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method.
- ClinicalTrials.gov ID
- NCT02874638
- Acronym / sponsor ID
- EA3 / IAAO-EA3
- Conditions
- Increased Metabolic Requirement, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 Aug 2016 (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).
The biological value of protein depends on its amino acid composition. Essential amino acids are believed to have main role on whole body protein metabolism. However, it remains to be determined what role non-essential amino acids (NEAA) may have in regulating protein metabolism and contributing to the increased protein requirements after endurance exercise.
The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. However, the IAAO method has never been utilized for assessing the effect of NEAA on protein requirements after endurance exercise.
The objective of the current study is to investigate the importance of NEAA for endurance-trained male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BASE egg protein | Experimental | Dietary Supplement: BASE egg protein0.8 g/kg/d of BASE protein provided as crystalline amino acid made after egg protein. |
| BCAA-enriched egg protein | Experimental | Dietary Supplement: BCAA-enriched egg proteinbranched-chain amino acid-enriched egg protein |
| small amount of essential amino acids | Experimental | Dietary Supplement: small amount of essential amino acidssmall amount of essential amino acids made after egg protein, which is equivalent to the amount of essential amino acids in BASE |
| large amount of essential amino acids | Experimental | Dietary Supplement: large amount of essential amino acidslarge amount of essential amino acids made after egg protein, which is equivalent to the amount of amino acids in BCAA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- endurance-trained participants who regularly run more than 40 km/week
- Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold, in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
- Ability to complete the 16-km familiarization run in session 2
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 |
|---|---|---|
| BASE egg protein0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein | Dietary supplement | BASE egg protein |
| BCAA-enriched egg proteinBCAA-enriched egg protein provided as crystalline amino acid. | Dietary supplement | BCAA-enriched egg protein |
| small amount of essential amino acidsessential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein | Dietary supplement | small amount of essential amino acids |
| large amount of essential amino acidsessential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein | Dietary supplement | large amount of essential amino acids |
Primary outcome
13CO2 (carbon dioxide) excretion rate (μmol/kg/h)
Time frame: at 8 hours after the end of exercise]
8 hours after exercise followed by ingesting 13C-labelled phenylalanine and one of 5 different amount of amino acids intake, 13CO2 excretion rate is determined by multiplying the enrichment of 13CO2 in breath measured by Mass spectrometry and CO2 production rate measured by metabolic cart.
1 secondary outcome
[13C]phenylalanine oxidation rate (μmol/kg/h)
Time frame: at 8 hours after the end of exercise
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 1 Apr 2019.
- Individual participant dataSharing planned: No
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.
Daniel Moore, Ph.D. principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing BASE egg protein, BCAA-enriched egg protein and small amount of essential amino acids 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 3 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 1 Apr 2019. 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.
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 rate (μmol/kg/h) (time frame: at 8 hours after the end of exercise]). 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 1 Apr 2019.