UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059225 |
|---|---|
| Receipt number | R000067510 |
| Scientific Title | A Systematic Review of the Transient Alleviating Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Psychological Stress and Subjective Fatigue |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/29 16:30:53 |
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Basic information
Public title
A Systematic Review of the Transient Alleviating Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Psychological Stress and Subjective Fatigue
Acronym
A Systematic Review of the Transient Alleviating Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Psychological Stress and Subjective Fatigue
Scientific Title
A Systematic Review of the Transient Alleviating Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Psychological Stress and Subjective Fatigue
Scientific Title:Acronym
A Systematic Review of the Transient Alleviating Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Psychological Stress and Subjective Fatigue
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to evaluate the transient effects of Gamma-Aminobutyric Acid (GABA) supplementation on psychological stress and subjective fatigue in healthy adult males and females, in comparison with placebo administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress biomarkers, autonomic nervous system activity, electroencephalographic (EEG) measures (alpha and beta waves), and subjective assessments (Visual Analog Scale [VAS], Profile of Mood States [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
Participants (P)
Participants were defined as healthy adult men and women who subjectively experience transient psychological stress and fatigue. Individuals with diagnosed medical conditions, minors, pregnant or lactating women were excluded. Those experiencing prolonged psychological stress or fatigue were also excluded due to the potential presence of underlying health conditions. However, individuals who performed stress-inducing tasks during the study period and subsequently reported transient psychological stress or fatigue were included.
Intervention (I)
Intervention was defined as oral intake of foods containing gamma-aminobutyric acid (GABA). As the focus was on transient effects, intake was primarily single-dose. Studies with intake periods of several days to one week were considered if the content clearly targeted transient psychological stress and fatigue. Based on previous research, studies administering 25mg to 100mg of GABA were included, with 28mg commonly regarded as an effective dose. Studies were grouped by dosage: <=25mg, <=50mg, and <=100mg. Studies with unclear GABA content were excluded.
Comparison (C)
Comparison was defined as oral intake of foods not containing GABA. Studies containing ingredients known to affect outcomes were generally excluded. However, studies with no intake or with trace amounts of such ingredients deemed unlikely to influence outcomes were included. No further subgrouping was performed; all studies meeting these criteria were treated as a single comparison group.
Outcome (O)
The primary outcome was defined as transient alleviation of psychological stress and fatigue. Both objective and subjective indicators were evaluated, including:
stress biomarkers
autonomic nervous system activity
electroencephalographic (EEG) measures (alpha and beta waves)
subjective assessments (VAS, POMS)
Key exclusion criteria
Exclude trials that do not meet the selection criteria, such as those including individuals with diseases.
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
Matsumoto Trading 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
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
| 2025 | Year | 09 | 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
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The search strategy involved using databases such as PubMed, JDream III, UMIN, and ClinicalTrials.gov. Reviewers A and B collaboratively developed search queries based on the research question and the PICOS framework. Where possible, thesaurus terms provided by each database were prioritized and combined with free-text keywords. Details of the search queries are documented in Appendix Form V-5. In addition to these databases, studies were also identified using the Consumer Affairs Agency's notification information search system, focusing on cases where GABA was submitted as a functional ingredient and included in research reviews.
Risk of bias was assessed across several domains, including selection bias related to randomization and allocation concealment, performance and detection bias involving blinding of participants and outcome assessors, attrition bias concerning analysis methods and incomplete outcome data, selective outcome reporting, other sources of bias, overall assessment, and the indirectness of individual studies. Each domain was rated as high, moderate or suspected, or low risk.
Certainty of evidence was evaluated for each outcome based on the risk of bias, indirectness, imprecision, inconsistency, and other factors such as publication bias. Each domain was rated using three levels: high, moderate or suspected, and low. The overall certainty of evidence was graded into four levels: A for high, B for moderate, C for low, and D for very low.
Management information
Registered date
| 2025 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067510
