UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058547 |
|---|---|
| Receipt number | R000066812 |
| Scientific Title | Systematic Review of the Functional Effects of GABA on Skin Elasticity |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/22 15:07:44 |
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Basic information
Public title
Systematic Review of the Functional Effects of GABA on Skin Elasticity
Acronym
Systematic Review of the Functional Effects of GABA on Skin Elasticity
Scientific Title
Systematic Review of the Functional Effects of GABA on Skin Elasticity
Scientific Title:Acronym
Systematic Review of the Functional Effects of GABA on Skin Elasticity
Region
| Japan |
Condition
Condition
healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to investigate whether oral administration of GABA enhances skin elasticity in healthy adult males and females, in comparison to a placebo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin Elasticity
Key secondary outcomes
Skin Hydration
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
The study targeted healthy adult men and women as participants. Given the absence of standardized clinical criteria to distinguish between healthy and diseased individuals based on skin elasticity, no numerical thresholds were applied to define skin health. Instead, individuals were excluded from the healthy cohort if they had received a medical diagnosis, undergone dermatological procedures beyond routine skincare, or used pharmaceutical products. Furthermore, individuals with any diagnosed medical conditions, minors, pregnant women, and lactating women were also excluded from participation.
Intervention
The intervention consisted of the oral intake of a food product containing gamma-aminobutyric acid (GABA). Data were collected at three time points: 4 weeks, 8 weeks, and 12 weeks after the start of intake. Participants were categorized into three groups based on their daily GABA intake: less than 30 mg, 30-99 mg, and 100 mg or more. Products with unclear GABA content were excluded from the analysis.
Control
The control condition was defined as the oral intake of food products that do not contain gamma-aminobutyric acid (GABA). In principle, products containing GABA or other ingredients known to affect the study outcomes were excluded. However, studies involving non-intake or products containing only trace amounts of such ingredients-judged unlikely to influence the outcomes-were permitted to be included in the control group
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
acqua.verde AWAJI
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 | 07 | Month | 24 | 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 | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 24 | 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 collaboratively developed search queries corresponding to the research question and PICOS framework. Where applicable, thesaurus terms provided by each database were prioritized, supplemented with free-text keywords. Detailed search strategies are documented in Supplementary Form (5)-5. Additionally, a consumer affairs notification database was used to identify studies included in research reviews, based on cases where GABA was registered as a functional ingredient.
Risk of Bias Assessment
Risk of bias was evaluated across the following domains: (1) selection bias (randomization and allocation concealment), (2) performance and detection bias (blinding of participants and outcome assessors), (3) attrition bias (analysis methods and incomplete outcome data), (4) selective outcome reporting, (5) other sources of bias, (6) overall assessment, and (7) indirectness of individual studies. Each domain was rated as "High," "Unclear," or "Low" risk based on the level of concern.
Certainty of Evidence
Certainty of evidence was assessed for each outcome based on risk of bias, indirectness, imprecision, inconsistency, and other factors (e.g., publication bias). Each domain was rated as "Not serious," "Serious," or "Very serious." Overall certainty was graded into four levels: High (A), Moderate (B), Low (C), and Very Low (D).
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066812
