UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054998 |
|---|---|
| Receipt number | R000062834 |
| Scientific Title | Effect of oral Gamma-Aminobutyric Acid(GABA) administration on stress reduction and relaxation in healthy adults:A systematic review |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/17 16:48:30 |
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Basic information
Public title
Effect of oral Gamma-Aminobutyric Acid(GABA) administration on stress reduction and relaxation : A systematic review
Acronym
Effect of oral GABA administration on stress reduction and relaxation:A systematic review
Scientific Title
Effect of oral Gamma-Aminobutyric Acid(GABA) administration on stress reduction and relaxation in healthy adults:A systematic review
Scientific Title:Acronym
Effect of oral GABA administration on stress reduction and relaxation in healthy adults:A systematic review
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify whether GABA intake by healthy adults has a relaxing effect and reduces temporary mental stress caused by work or study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress(chromogranin A, cortisol, autonomic nervous system activity, electroencephalography, VAS, POMS)
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
Studies that meet the following PICOS and conditions
P:healthy adults
I:Foods containing GABA
C:Foods not containing GABA
O:Stress reduction, relaxation
S:Randomized controlled trial or equivalent
-study period : single dose
-Languages: English, Japanese
-Publication status: Original peer-reviewed paper
Key exclusion criteria
-Examination for the following persons : patient, expectant and nursing mothers
-Studies using test products that contain ingredients other than GABA that affect test results.
-in vivo, in vitro
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Takeuchi |
Organization
Association of Japan CAM
Division name
N/A
Zip code
1510053
Address
#306 Onogibiru,3-46-16 Yoyogi, Shibuya-ku, Tokyo
TEL
0364574911
info@ajcam.biz
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N/A
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Unifrutti Japan Corporation
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
Japan Clinical Trial Association
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574666
info@yakujihou.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 | 07 | Month | 22 | 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 | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Literature database to be used
-PubMed
-JDream3
-Cochrane Library
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
