UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036581 |
|---|---|
| Receipt number | R000041677 |
| Scientific Title | Effect of amino acids intake on exercise-induced decrease of executive function |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2019/04/23 17:52:52 |
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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
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
soya.hideaki.gt@u.tsukuba.ac.jp
Public contact
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
takuya_toyoda@ajinomoto.com
Sponsor or person
Institute
Tsukuba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041677
