UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method
Title of the study (Brief title)	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	Daniel Moore
Organization	University of Toronto
Division name	Faculty of kinesiology and physical education
Address	100 Devonshire Place, Toronto, Ontario
TEL	+1-416-946-4088
Email	dr.moore@utoronto.ca

Public contact
Name of contact person	Hiroyuki KATO
Organization	University of Toronto
Division name	Faculty of Kinesiology and physical education
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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