UMIN-CTR Clinical Trial

Basic information
Public title	Effect of amino acid intake on intermittent exercise performance.
Acronym	Effect of amino acid intake on intermittent exercise performance.
Scientific Title	Effect of amino acid intake on intermittent exercise performance.
Scientific Title:Acronym	Effect of amino acid intake on intermittent exercise performance.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of amino acid intake on intermittent exercise performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	power output by bicycle ergometer
Key secondary outcomes	VO2, VCO2, Blood pH, Blood bicarbonate(HCO3-) level, Blood catecholamine level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	(1)Amino acid intake (2)Exercise loading by bicycle ergometer (3)Blood sampling during or after exercise (4)7 days wash out (5)Placebo intake (6)Exercise loading by bicycle ergometer (7)Blood sampling during or after exercise
Interventions/Control_2	(1)Placebo intake (2)Exercise loading by bicycle ergometer (3)Blood sampling during or after exercise (4)7 days wash out (5)Amino acid intake (6)Exercise loading by bicycle ergometer (7)Blood sampling during or after exercise
Interventions/Control_3	(1)Amino acids mixture intake (2)Exercise loading by bicycle ergometer (3)Blood sampling during or after exercise (4)7 days wash out (5)Placebo intake (6)Exercise loading by bicycle ergometer (7)Blood sampling during or after exercise
Interventions/Control_4	(1)Placebo intake (2)Exercise loading by bicycle ergometer (3)Blood sampling during or after exercise (4)7 days wash out (5)Amino acids mixture intake (6)Exercise loading by bicycle ergometer (7)Blood sampling during or after exercise
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	(1)A healthy Japanese man aged from 20 to 29 years old at the time of informed consent. (2) A person who have execise habits (3) A person who provided informed consent by a document
Key exclusion criteria	(1)A person who has surgical injury and chronic disease. (2) A person who has participated in other clinical study and monitor test or are planned to participate in other clinical study. (3) A person who had 200 mL or more of blood taken within the past 12 weeks. (4) A person who got sick by blood collection in the past. (5) A person who is judged to be inappropriate for current study based on the medical chart by medical doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazushige Middle name Last name Goto
Organization	Ritsumeikan University
Division name	College of Sport and Health Science
Zip code	525-8577
Address	1-1-1 Nojihigashi, Kusatsu shi, Shiga
TEL	077-599-4127
Email	kagoto@fc.ritsumei.ac.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name koizumi
Organization	Ajinomoto Co., Inc
Division name	Human health & nutrition group, Institute of food sciences & technologies
Zip code	210-8681
Address	1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Homepage URL
Email	Tomonori_koizumi@ajinomoto.com

Sponsor
Institute	Ritsumeikan University
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	Ritsumeikan University
Address	1-1-1 Nojihigashi, Kusatsu shi, Shiga
Tel	077-561-3412
Email	b-rinri@st.ritsumei.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2024 Year 01 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 08 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 08 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042507