UMIN-CTR Clinical Trial

Basic information
Public title	Effect of amino acids intake on exercise-induced decrease of executive function
Acronym	Effect of amino acids intake on exercise-induced decrease of executive function
Scientific Title	Effect of amino acids intake on exercise-induced decrease of executive function
Scientific Title:Acronym	Effect of amino acids intake on exercise-induced decrease of executive function
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the effect of amino acids intake on executive function reduced by exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	executive function (accuracy, reaction time in the stroop test)
Key secondary outcomes	plasma tryptophan metabolites plasma amino acids concentration inflammatory response prefrontal cortex activity

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	exposure to hypoxia stroop task amino acids intake exercise stroop task
Interventions/Control_2	exposure to hypoxia stroop task placebo intake exercise stroop task
Interventions/Control_3
Interventions/Control_4
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	40 years-old >=
Gender	Male
Key inclusion criteria	A healthy male adult aged 20 to 40 years old. A subject who provided informed consent by a document. A subject who is Japanese native speaker. A right handed subject.
Key exclusion criteria	Any subject considered to be difficult to exercise due to surgical injury or medical disorder. Any subject who has respiratory disease. Any subject who has cardiovascular diseases. Any subject who donated blood within 12 weeks before the start of the study. Any subject who is considered as inappropriate for participating into the study at the judgment of principal investigator.
Target sample size	32

Research contact person
Last name of lead principal investigator	1st name Hideaki Middle name Last name Soya
Organization	Tsukuba University
Division name	Faculty of Health and Sport Sciences
Zip code	305-8574
Address	1-1-1, tennodai, Tsukuba-shi, Ibaraki
TEL	029-853-2620
Email	soya.hideaki.gt@u.tsukuba.ac.jp

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

Sponsor
Institute	Tsukuba University
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tsukuba University research ethics committee
Address	1-1-1, tennodai, Tsukuba-shi, Ibaraki
Tel	029-853-2571
Email	hitorinri@un.tsukuba.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	2025 Year 02 Month 28 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 04 Month 09 Day
Date of IRB
Anticipated trial start date	2019 Year 04 Month 09 Day
Last follow-up date	2019 Year 07 Month 04 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 04 Month 23 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041677