UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056710 |
|---|---|
| Receipt number | R000064750 |
| Scientific Title | Systematic review of the effects of GABA intake on elevated blood pressure |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/14 14:01:30 |
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Basic information
Public title
Systematic review of the effects of GABA intake on elevated blood pressure
Acronym
SR of the effect of GABA intake on elevated blood pressure
Scientific Title
Systematic review of the effects of GABA intake on elevated blood pressure
Scientific Title:Acronym
SR of the effect of GABA intake on elevated blood pressure
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the effects of GABA intake in healthy but moderately elevated blood pressure in a systematic review.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
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]
Age: Adult (18 years old and over, no upper limit applies)
Gender: Both men and women
Health Condition: Healthy
Include patients with normal hypertension and degree I hypertension with outpatient blood pressure
BMI: Standard weight (18.5 to 25) and obesity 1 degree (25 to 30)
[Intervention]
Foods containing GABA (regardless of food form) should be taken orally. The duration of intake should not be less than 12 weeks.
[Comparison]
Intake of placebo without GABA
[Outcomes]
Evaluate whether there is a function of lowering blood pressure.
[Research design]
Conducting randomized controlled trials
Studies that use foods that use multiple ingredients in addition to GABA as functional ingredients are not included
Only peer-reviewed original papers are eligible.
Key exclusion criteria
Trials that include women who are pregnant or breastfeeding, women who are planning to become pregnant, or people who are being treated for hypertension.
Studies with unknown GABA content.
Papers citing the test results of the original paper, explanatory papers, abstracts of conference presentations, conference proceedings.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Graduate School of Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Sciences
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan
TEL
092-802-4946
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Hattori |
Organization
Kurume Research Park Co., Ltd
Division name
Bio Project Division
Zip code
839-0864
Address
1-1 Hyakunenkoen,Kurume City, Fukuoka
TEL
0942-37-6124
Homepage URL
fbv@kurume-rp.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kurume Research Park Co., Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Evaluation Center of Health and Nutrition Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable for the systematic review
Address
N/A
Tel
0942-37-6124
fbv@kurume-rp.co.jp
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 | 01 | Month | 15 | 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 | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research process involves a team of three experienced individuals, A, B, and C, who independently conduct searches using academic article databases and clinical trial registries, as well as the Foods with Functional Claims Notification Database. In cases where their findings do not align, discussions are held, and if necessary, a fourth member, D, will make the final decision on the acceptance or rejection of results.
The selection of studies and data extraction is similarly conducted independently by A, B, and C, with a structured approach to resolving discrepancies through consultation and, if needed, confirmation by D. The evaluation of bias risk in research papers is performed using established guidelines, and any uncertainties in the data are addressed by contacting the authors directly.
To assess the reliability of studies, the team evaluates various factors such as indirectness, inaccuracy, and publication bias, referencing specific clinical practice guidelines. In synthesizing results, studies with similar designs and high PICO item similarity are pooled, while those with high bias risk are excluded. Missing data is addressed by reaching out to authors, and if unresponsive, it is treated as a missing value. Meta-analysis is conducted using statistical software, with subgroup analyses performed in cases of high heterogeneity.
The certainty of the evidence is quantified based on the evaluation of indirectness, inaccuracy, inconsistency, and publication bias, with a scoring system that categorizes the evidence into high, medium, low, and very low certainty levels. This structured approach ensures a comprehensive and rigorous evaluation of the research findings.
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064750
