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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023975
Receipt No. R000027540
Scientific Title Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Date of disclosure of the study information 2016/09/12
Last modified on 2017/09/05

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Basic information
Public title Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Acronym Effect of Non-essential Amino Acids on Protein Requirements
Scientific Title Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Scientific Title:Acronym Effect of Non-essential Amino Acids on Protein Requirements
Region
North America

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the current study is to investigate the importance of Non Essential Amino Acids for endurance-trained male subjects
Basic objectives2 Others
Basic objectives -Others The objective of the current study is to investigate the importance of Non Essential Amino Acids for endurance-trained male subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 13CO2 (carbon dioxide) excretion rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 BASE egg protein
0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
Interventions/Control_2 BCAA-enriched egg protein
BCAA-enriched egg protein provided as crystalline amino acid.
Interventions/Control_3 small amount of essential amino acids
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
Interventions/Control_4 large amount of essential amino acids
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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria -endurance-trained participants who regularly run more than 40 km/week.
-Ability to complete the 16-km familiarization run.
Key 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
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daniel Moore
Organization University of Toronto
Division name Faculty of kinesiology and physical education
Zip code
Address 100 Devonshire Place, Toronto, Ontario
TEL +1-416-946-4088
Email dr.moore@utoronto.ca

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki KATO
Organization University of Toronto
Division name Faculty of Kinesiology and physical education
Zip code
Address 100 Devonshire Place, Toronto, Ontario
TEL +1-416-946-5620
Homepage URL
Email h.kato@utoronto.ca

Sponsor
Institute University of Toronto
Institute
Department

Funding Source
Organization Ajinomoto co. Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02874638
Org. issuing International ID_1 clinicaltrial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 08 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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