UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055998 |
|---|---|
| Receipt number | R000063978 |
| Scientific Title | Systematic Review on the effects of GABA intake on mental stress and fatigue |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/10/30 17:35:43 |
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Basic information
Public title
Systematic Review on the effects of GABA intake on mental stress and fatigue
Acronym
SR of GABA's effects on stress and fatigue
Scientific Title
Systematic Review on the effects of GABA intake on mental stress and fatigue
Scientific Title:Acronym
SR of GABA's effects on stress and fatigue
Region
| Japan |
Condition
Condition
mental stress and fatigue
Classification by specialty
| Medicine in general | Neurology | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
a literature review to investigate whether the intake of GABA affects to alleviate mental stress and fatigue pressure in healthy adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram (EEG) measurement, quality of life (QOL) survey (POMS2, VAS etc.)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Health Adults
Key exclusion criteria
Minors, pregnant women (including those planning to become pregnant), nursing mothers, patients with mental disorders
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Mochida |
Organization
KinoKen Co., Ltd.
Division name
R&D
Zip code
150-0031
Address
City Court Sakuragaoka 408, 23-17 Sakuragaoka-cho, Shibuya-ku, Tokyo, Japan
TEL
03-4405-4175
kinoken.todokede@gmail.com
Public contact
Name of contact person
| 1st name | Kiichiro |
| Middle name | |
| Last name | Mochida |
Organization
KinoKen Co., Ltd.
Division name
R&D
Zip code
150-0031
Address
City Court Sakuragaoka 408, 23-17 Sakuragaoka-cho, Shibuya-ku, Tokyo, Japan
TEL
03-4405-4175
Homepage URL
kinoken.todokede@gmail.com
Sponsor or person
Institute
KinoKen Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable for the systematic review
Address
Not applicable for the systematic review
Tel
090-3499-6077
info@rctjapan.org
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 | 10 | Month | 30 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Systematic review for Foods with Function Claims
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063978
