UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054080 |
|---|---|
| Receipt number | R000061752 |
| Scientific Title | Administration of BCAA Combined with Phenylalanine and Methionine Potently Promotes Fatigue Recovery: Potential Treatment for ADHD |
| Date of disclosure of the study information | 2024/04/10 |
| Last modified on | 2024/04/06 20:14:15 |
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Basic information
Public title
Brain fatigue alleviation nutritional supplement test
Acronym
Brain fatigue supplement
Scientific Title
Administration of BCAA Combined with Phenylalanine and Methionine Potently Promotes Fatigue Recovery: Potential Treatment for ADHD
Scientific Title:Acronym
Amino acids supplement for mental fatigue
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
Condition
Condition
ADHD
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Because fully eliminating the causes of fatigue is a daunting challenge, I sought
to develop a powerful nutritional strategy to combat fatigue. This study investigated whether
dietary supplementation with BCAAs plus phenylalanine and methionine (BPM) or BCAAs
plus 2-amino-2-norbornanecarboxylic acid (BCAAs + BCH) improves central fatigue in rats
and humans compared with BCAAs alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy rate represents the effectiveness value for all subjects in the experimental group whose fatigue scores decreased compared to the placebo group. After administering a dietary supplement containing BCAA plus phenylalanine (125 mg kg-1) and methionine (75 mg kg-1) (BPM) to humans, central fatigue was assessed by POMS testing. 105 minutes after administration was used for evaluation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Interventions:
BCAAs
Controls:
Placebo
Interventions/Control_2
Interventions:
BCAAs plus tyrosine (BY)
Controls:
Placebo
Interventions/Control_3
Interventions:
BPM
Controls:
Placebo
Interventions/Control_4
Interventions:
BPM plus tyrosine (BPMY)
Controls:
Placebo
Interventions/Control_5
Interventions:
BY plus glutamine (BYG)
Controls:
Placebo
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy eight men and eight women aged 20 or 21 years.
Key exclusion criteria
Subjects with chronic physical and mental fatigue.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Yamamoto |
Organization
Tezukayama University
Division name
Department of Psychology
Zip code
6318585
Address
3-1-3 Gakuenminami, Nara City, Nara Prefecture
TEL
+81742414716
yamamoto@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Yamamoto |
Organization
Tezukayama University
Division name
Department of Psychology
Zip code
5630105
Address
3-33-5 sinkofudai Toyonocho Toyonogun Osaka Prefecture
TEL
+81742411621
Homepage URL
takaoxford@gmail.com
Sponsor or person
Institute
Japan Society for the Promotion of Science
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Research Ethics Committee
Address
3-1-3 Gakuenminami, Nara City, Nara Prefecture
Tel
+81742414716
y-sakamoto@jimu.tezukayama-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
| 2024 | Year | 04 | Month | 10 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061752
