UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058577 |
|---|---|
| Receipt number | R000066899 |
| Scientific Title | Effects of Branched-Chain Amino Acid Supplementation on Central Fatigue |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 10:54:45 |
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Basic information
Public title
Effects of Branched-Chain Amino Acid Supplementation on Central Fatigue
Acronym
Effects of Branched-Chain Amino Acid Supplementation on Central Fatigue
Scientific Title
Effects of Branched-Chain Amino Acid Supplementation on Central Fatigue
Scientific Title:Acronym
Effects of Branched-Chain Amino Acid Supplementation on Central Fatigue
Region
| Japan |
Condition
Condition
young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify whether branched-chain amino acids supplementation reduces subjective fatigue, task performance decline, and scores on subjective fatigue-related rating scales in young healthy individuals experiencing central fatigue induced by cognitive tasks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Fatigue Symptoms Scale for Youth (SFS-Y)
Key secondary outcomes
subjective fatigue
cognitive task performance
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume each of the following test beverages, which are widely available as general food products, once each. Fifteen minutes after ingestion, a 30-minute central fatigue-inducing task will be performed.
BCAA beverage: 2000 mg of branched-chain amino acids (BCAAs) in granule form dissolved in 200 mL of water.
Interventions/Control_2
Participants will consume each of the following test beverages, which are widely available as general food products, once each. Fifteen minutes after ingestion, a 30-minute central fatigue-inducing task will be performed.
Placebo beverage: A beverage with similar caloric content but without BCAAs, dissolved in 200 mL of water.
Interventions/Control_3
Participants will consume each of the following test beverages, which are widely available as general food products, once each. Fifteen minutes after ingestion, a 30-minute central fatigue-inducing task will be performed.
Water: 200 mL of natural mineral water.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 years or older and under 25 years, with no health problems.
2.Individuals who have received a full explanation of the study, sufficiently understood the contents, and voluntarily provided informed consent to participate.
Key exclusion criteria
1.Individuals with a history of allergies or other medical conditions related to dairy products.
2.Individuals with any current medical conditions under treatment.
3.Individuals who regularly take medications or supplements that may affect concentration.
4.Any other individuals deemed inappropriate as study participants by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
as-51@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Atsushi Sawada
Funding Source
Organization
Health Sciences University of Hokkaido
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of School of Rehabilitaion Sciences, Health Sciences University of Hokkaido
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
Tel
0133-23-1211
kyo-reha@hoku-iryo-u.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 | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066899
