UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059224 |
|---|---|
| Receipt number | R000067466 |
| Scientific Title | Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/22 09:28:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality
Acronym
Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality
Scientific Title
Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality
Scientific Title:Acronym
Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine whether the intake of GABA improves sleep quality in healthy adult men and women, compared to placebo intake, by administering GABA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalography,VAS,Pittsburgh Sleep Quality Index,OSA-MA
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)
Healthy adult men and women were included. Individuals with diagnosed diseases, minors, pregnant or lactating women were excluded. Those with temporary sleep-related concerns were considered healthy if they met no exclusion criteria, but were categorized separately from those without such concerns. Sleep concerns were defined as temporary and distinct from clinical sleep disorders.
Intervention (I)
The intervention was oral intake of GABA-containing food products. Previous studies have employed intake durations ranging from one to twelve weeks. However, considering that prolonged supplementation may extend beyond the scope of transient sleep-related complaints and potentially influence broader physiological parameters, studies exceeding four weeks were, as a general protocol, designed with stratified cohorts to account for duration-dependent effects. All previous studies used 100 mg of GABA, which was adopted as the assumed effective dose. Studies with higher or lower doses were considered for subgroup analysis. Studies without clear dosage information were excluded.
Comparison (C)
The comparison was oral intake of food products without GABA. Studies containing ingredients known to affect sleep were excluded unless the amount was negligible or deemed not to influence outcomes. All qualifying studies were grouped together without further subdivision.
Outcome (O)
The primary outcome was improvement in sleep quality. EEG measurement was considered essential, following recommendations by the Japanese Society of Sleep Research. Additionally, subjective assessments of sleep restfulness were included, based on the Ministry of Health's "Sleep Guidelines for Health Promotion 2023." Subjective measures included the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Oguri-Shirakawa-Azumi Sleep Inventory for Middle-Aged and Aged (OSA-MA).
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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search Strategy
Database searches were conducted using PubMed, JDream III, UMIN, and ClinicalTrials.gov. Reviewers A and B discussed and formulated search queries based on the research question and PICOS framework. Where available, thesaurus terms provided by each database were prioritized and combined with free-text keywords. Detailed search strategies are described in Appendix Form (V)-5. Additionally, the Consumer Affairs Agency's notification database was used to identify studies adopted in research reviews where GABA was registered as a functional ingredient.
Risk of Bias Assessment
Risk of bias was assessed in the following domains: (1) selection bias (randomization, allocation concealment), (2) performance and detection bias (blinding of participants and outcome assessors), (3) attrition bias (analysis methods, incomplete outcome data), (4) selective outcome reporting, (5) other biases, (6) overall assessment, and (7) indirectness of individual studies. Each domain was rated as "high", "unclear", or "low" risk.
Certainty of Evidence
Certainty of evidence was evaluated for each outcome based on risk of bias, indirectness, imprecision, inconsistency, and other factors (e.g., publication bias). Each domain was rated as "high", "unclear", or "low". Overall certainty was graded into four levels: high (A), moderate (B), low (C), and very low (D).
Management information
Registered date
| 2025 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067466
