Increased Metabolic RequirementEANCT02628249
Rate-limiting Amino Acids in Endurance-trained Athlete
A study testing Base protein, Sufficient protein and Branched chain 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 the amino acid composition. 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?
- Base protein, Sufficient protein and Branched chain amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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: Application of Indicator Amino Acid Oxidation Method to Investigate the Rate-limiting Amino Acids in Endurance Trained Athlete
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 the amino acid composition. As liebig's law of the minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid. In this case, the first rate limiting amino acid determines protein intakes to maximize the protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the biological value of its protein diet.
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 determining the first rate limiting amino acid.
Therefore, the purpose of this study is to address of IAAO method to be applied for determining the rate-limiting amino acid in endurance athlete.
- Conditions
- Increased Metabolic Requirement, Healthy
- Being tested
- Base protein, Sufficient protein, Branched chain amino acids, Essential amino acids, Non essential amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base proteinDietary supplement
0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
Sufficient proteinDietary supplement
1.75 g/kg/d protein provided as crystalline amino acid modeled after egg protein.
Branched chain amino acidsDietary supplement
Branched chain amino acids modeled after egg protein.
Essential amino acidsDietary supplement
Essential amino acids modeled after egg protein.
Non essential amino acidsDietary supplement
Non essential amino acids modeled after egg protein.
| Study group | Role | What they receive |
|---|---|---|
| Base protein | Experimental | 0.8 g/kg/d of protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: Base protein |
| Sufficient protein | Experimental | 1.75 g/kg/d protein provided as crystalline amino acid made after egg protein. Receives: Dietary Supplement: Sufficient protein |
| Base + BCAA | Experimental | Base protein intake + Branched chain amino acids Receives: Dietary Supplement: Base protein; Dietary Supplement: Branched chain amino acids |
| Base + EAA | Experimental | Base protein intake + essential amino acids. Receives: Dietary Supplement: Base protein; Dietary Supplement: Essential amino acids |
| Base + NEAA | Experimental | Base protein intake + non essential amino acids Receives: Dietary Supplement: Base protein; Dietary Supplement: Non 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 posted11 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionDec 2017
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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628249
- Sponsor's protocol ID
- IAAO-EA
- Acronym
- EA
- Status last verified
- Mar 2019
- First submitted
- 7 Dec 2015
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kato H, Suzuki K, Bannai M, Moore DR. Branched-Chain Amino Acids Are the Primary Limiting Amino Acids in the Diets of Endurance-Trained Men after a Bout of Prolonged Exercise. J Nutr. 2018 Jun 1;148(6):925-931. doi: 10.1093/jn/nxy048.
PubMed 29746639
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
- Application of Indicator Amino Acid Oxidation Method to Investigate the Rate-limiting Amino Acids in Endurance Trained Athlete
- ClinicalTrials.gov ID
- NCT02628249
- Acronym / sponsor ID
- EA / IAAO-EA
- Conditions
- Increased Metabolic Requirement, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Dec 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).
The biological value of protein depends on the amino acid composition. As liebig's law of the minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid. In this case, the first rate limiting amino acid determines protein intakes to maximize the protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the biological value of its protein diet.
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 determining the first rate limiting amino acid.
Therefore, the purpose of this study is to address of IAAO method to be applied for determining the rate-limiting amino acid in endurance athlete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Base protein | Experimental | Dietary Supplement: Base protein0.8 g/kg/d of protein provided as crystalline amino acid made after egg protein. |
| Sufficient protein | Experimental | Dietary Supplement: Sufficient protein1.75 g/kg/d protein provided as crystalline amino acid made after egg protein. |
| Base + BCAA | Experimental | Dietary Supplement: Base protein, Dietary Supplement: Branched chain amino acidsBase protein intake + Branched chain amino acids |
| Base + EAA | Experimental | Dietary Supplement: Base protein, Dietary Supplement: Essential amino acidsBase protein intake + essential amino acids. |
| Base + NEAA | Experimental | Dietary Supplement: Base protein, Dietary Supplement: Non essential amino acidsBase protein intake + non essential amino acids |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 |
|---|---|---|
| Base protein0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein | Dietary supplement | Base + BCAA, Base + EAA, Base + NEAA, Base protein |
| Sufficient protein1.75 g/kg/d protein provided as crystalline amino acid modeled after egg protein. | Dietary supplement | Sufficient protein |
| Branched chain amino acidsBranched chain amino acids modeled after egg protein. | Dietary supplement | Base + BCAA |
| Essential amino acidsEssential amino acids modeled after egg protein. | Dietary supplement | Base + EAA |
| Non essential amino acidsNon essential amino acids modeled after egg protein. | Dietary supplement | Base + NEAA |
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.
- Derived from this study: PubMed 29746639Kato H, Suzuki K, Bannai M, Moore DR. Branched-Chain Amino Acids Are the Primary Limiting Amino Acids in the Diets of Endurance-Trained Men after a Bout of Prolonged Exercise. J Nutr. 2018 Jun 1;148(6):925-931. doi: 10.1093/jn/nxy048.
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 study testing Base protein, Sufficient protein and Branched chain 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 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 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?
On the ClinicalTrials.gov record for NCT02628249, 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 1 Apr 2019.