- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874638
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes (EA3)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: BASE egg protein
0.8 g/kg/d of BASE protein provided as crystalline amino acid made after egg protein.
|
0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
|
|
EXPERIMENTAL: BCAA-enriched egg protein
branched-chain amino acid-enriched egg protein
|
BCAA-enriched egg protein provided as crystalline amino acid.
|
|
EXPERIMENTAL: small amount of essential amino acids
small amount of essential amino acids made after egg protein, which is equivalent to the amount of essential amino acids in BASE
|
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
|
|
EXPERIMENTAL: large amount of essential amino acids
large amount of essential amino acids made after egg protein, which is equivalent to the amount of amino acids in BCAA
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at 8 hours after the end of exercise]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[13C]phenylalanine oxidation 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 dividing 13CO2 excretion rate by urinary enrichment of 13C-phenylalanine in breath measured by Mass spectrometry, and CO2 production rate measured by metabolic cart.
|
at 8 hours after the end of exercise
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Moore, Ph.D., University of Toronto
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IAAO-EA3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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