UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063090 |
|---|---|
| Receipt number | R000071929 |
| Scientific Title | Effects of continuous intake of gamma-aminobutyric acid (GABA) on blood pressure in healthy adults with high-normal blood pressure: a systematic review |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 10:29:38 |
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Basic information
Public title
Effects of continuous intake of GABA on blood pressure in healthy adults with high-normal blood pressure: a systematic review
Acronym
GABA and Blood Pressure SR
Scientific Title
Effects of continuous intake of gamma-aminobutyric acid (GABA) on blood pressure in healthy adults with high-normal blood pressure: a systematic review
Scientific Title:Acronym
GABA-BP-SR
Region
| Japan |
Condition
Condition
Healthy adults with high-normal blood pressure
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically evaluate the effects of continuous intake of gamma-aminobutyric acid (GABA) on blood pressure in healthy individuals with high-normal blood pressure, compared with no intake or placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure (SBP), Diastolic blood pressure (DBP)
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
P:Healthy adults (in principle aged 18 years or older) with high-normal blood pressure. Studies of populations comprising both high-normal blood pressure and grade I hypertension are eligible when the study's enrollment criteria include participants with high-normal blood pressure; availability of stratified data does not affect eligibility
I:Continuous intake of GABA for 12 weeks in principle (intake periods of 11 to 13 weeks are eligible)
C:Placebo or no intervention
Key exclusion criteria
(1) Animal studies, in vitro studies, and studies enrolling only diseased participants; (2) studies whose blood pressure enrollment threshold is set at a systolic blood pressure of 140 mmHg or higher, or a diastolic blood pressure of 90 mmHg or higher (i.e., designed to enroll only participants with grade I or higher hypertension); (3) studies for which outcome data at 11 to 13 weeks (77-91 days) of intake are not available
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
| 2026 | Year | 09 | Month | 29 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This systematic review (SR) is intended to be used for a notification submission of a Food with Function Claims (FFC).
Information sources: PubMed, JDream III, UMIN-CTR, ClinicalTrials.gov, and hand-searching.
Where appropriate, a meta-analysis will be conducted using a random-effects model with restricted maximum likelihood (REML) estimation and Hartung-Knapp adjustment in R version 4.5.3 using the metafor package.
The primary analysis will include all adopted studies. To assess the robustness of the findings, the following sensitivity analyses will be performed: (1) an analysis restricted to individuals with high-normal blood pressure (healthy subjects), and (2) an analysis restricted to studies with a low risk of bias (score = 0).
The certainty of the evidence will be evaluated using the GRADE approach and classified into four levels: High (A), Moderate (B), Low (C), and Very Low (D).
If any important amendments occur, the details and rationale for the changes will be clearly described and reflected in both the final report and the UMIN-CTR registration record.
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | 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=R000071929
