UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059902 |
|---|---|
| Receipt number | R000068507 |
| Scientific Title | Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/12/01 23:22:00 |
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Basic information
Public title
Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial
Acronym
Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial
Scientific Title
Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial
Scientific Title:Acronym
Impact of Pre-exam GABA Administration on Stress and Psychophysiological Conditions : A Parallel-Group Comparison Trial
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of GABA intake on anxiety reduction, sleep quality, and stress reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), a validated instrument for measuring both state and trait anxiety, to evaluate changes associated with GABA capsule intake
Key secondary outcomes
1)Changes in sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
2)To Evaluate changes in sleep quality using variations in nighttime sleep proportion measured by a smartwatch.
3)To Evaluate the impact on mental health (well-being) using the WHO-5 Well-Being Index.
4)To Evaluate physiological changes in stress using the measurement results of salivary alpha-amylase.
5)To Evaluate changes in concentration by having participants self-assess using a five-point Likert scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group: Participants will take one GABA capsule (500 mg) once upon waking.
Interventions/Control_2
Control group: Participants will take one placebo capsule (containing potato starch) once upon waking.
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
| 28 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who have received sufficient explanation about the purpose and contents of this research, have the ability to provide consent, voluntarily agreed after fully understanding the details, and provided written consent to participate.
2. Individuals who are not currently receiving treatment with psychotropic medications such as anxiolytics or antidepressants.
Key exclusion criteria
1)Individuals who decline to participate in the study of their own volition.
2)Individuals with known allergies to any of the ingredients of the GABA capsule product.
3)Individuals deemed ineligible at the discretion of the principal
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hoshi University
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501
Tel
03-3786-1011
y-hashiguchi@hoshi.ac.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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068507
