UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042638 |
|---|---|
| Receipt number | R000048458 |
| Scientific Title | Effect of essential amino acid-enriched food on exercise-induced cognitive improvement |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2025/04/09 12:58:33 |
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Basic information
Public title
Effect of essential amino acid-enriched food on exercise-induced alteration of cognitive function
Acronym
Effect of essential amino acid-enriched food on cognitive function
Scientific Title
Effect of essential amino acid-enriched food on exercise-induced cognitive improvement
Scientific Title:Acronym
Effect of essential amino acids on exercise-induced cognitive improvement
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of essential amino acid-enriched food on exercise-induced cognitive improvement and factors related to brain function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute cognitive function
Key secondary outcomes
Visual analog scale
Felt arousal scale
Rating of Perceived Exertion
Category-ration scale
The Profile of Mood States 2
Blood parameter
Brain derived neurotrophic factor
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One bout of exercise and essential amino acids (4000mg) intake in a day
Interventions/Control_2
One bout of exercise and placebo intake in a day
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Male aged 20 or higher and 29 or less years old.
2) Individuals who can make self-judgment and voluntarily provides written informed consent.
Key exclusion criteria
1) Individuals who have smoked within a year
2) Individuals who have cardiovascular diseases
3) Individuals who have psychiatric diseases such as depression (including self-declaration)
4) Individuals who have color and visual blindness
5) Individuals who have allergy to foods (soybeans)
6) Individuals who received more than 200 mL of blood collection within 12 weeks from the screening test.
7) Individuals who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Department of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Nojihigashi, Kusatsu-shi, Shiga
TEL
077-599-4134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Department of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Nojihigashi, Kusatsu-shi, Shiga
TEL
0775994134
Homepage URL
thashimo@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ajinomoto Co.,Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University Institutional Review Board
Address
1-1-1, Nojihigashi, Kusatsu-shi, Shiga
Tel
077-599-4175
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
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41598-023-49781-z
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1038/s41598-023-49781-z
Number of participants that the trial has enrolled
22
Results
The results suggested that essential amino acid (EAA) supplements ingestion has a positive effect on executive function (EF) after moderate-intensity aerobic exercise.
Results date posted
| 2025 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-two healthy young men
Participant flow
The participants were informed of the experimental procedures and potential risks and provided written informed consent to participate in the study.
No participants had any known neurologic, cardiovascular, or pulmonary disorders; color blindness; or abnormal vision.
The participants were instructed to avoid strenuous physical activity and abstain from caffeine and alcohol for 24 h before each experimental treatment.
Moreover, the participants also abstained from food for 12 h (overnight fasting) before each experiment and were not taking any medications that would affect cognitive function.
Adverse events
None
Outcome measures
cognitive function (executive function and recognition memory)
blood amino acids concentrations
blood brain-derived neurotrophic factor (BDNF)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048458
