UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051927 |
|---|---|
| Receipt number | R000059245 |
| Scientific Title | Psychological stress-reducing effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review with meta-analysis |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/02/19 08:17:21 |
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Basic information
Public title
Psychological stress-reducing effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review with meta-analysis
Acronym
Psychological stress-reducing effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review
Scientific Title
Psychological stress-reducing effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review with meta-analysis
Scientific Title:Acronym
Psychological stress-reducing effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether orally ingested GABA reduce psychological stress in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain waves, heart rate variability, salivary markers (cortisol, alpha-amylase, chromogranin A, IgA), Profile of Mood States (POMS), Visual Analogue Scale (VAS)
Key secondary outcomes
None
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
(PICOS)
Participant:
We will include healthy adults without illness (excluding pregnant women [[including those planning to become pregnant and lactating women].
Intervention:
Oral intake of test food containing GABA (regardless of the form and amount of intake)
Comparison:
Oral intake of test food without GABA, or no intervention
Outcome measurement:
Brain waves, heart rate variability, salivary markers (cortisol, alpha-amylase, chromogranin A, IgA), Profile of Mood States (POMS), Visual Analogue Scale (VAS)
Study design:
Randomized controlled parallel trials (RCT-P), randomized controlled crossover trials (RCT-C), quasi-randomized controlled parallel trials (qRCT-P), quasi randomized controlled crossover trials (qRCT-C), non-randomized controlled parallel trials (nonRCT-P), non-randomized controlled crossover trials (nonRCT-C), and non-randomized controlled trials
(PECOS)
Participant:
We will include healthy adults without illness (excluding pregnant women [[including those planning to become pregnant and lactating women].
Exposure
Oral intake of test food containing GABA (regardless of the form and amount of intake)
Comparison:
Oral intake of test food without GABA. If subgroup analysis of GABA intake amount has been conducted in a study, we define the least intake group as a non-exposure group.
Outcome measurement:
Brain waves, heart rate variability, salivary markers (cortisol, alpha-amylase, chromogranin A, IgA), Profile of Mood States (POMS), Visual Analogue Scale (VAS)
Study design:
Cohort studies and case-control studies.
(Language)
Eligibility is not restricted by language.
Key exclusion criteria
Exclude proceedings and unpublished studies which don't give us enough research details, and other gray documents that are difficult to verify.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
g167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Yoshida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
g167_0@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome CO.,LTD. Research Ethics Review Committee
Address
3-21-1 Nihonbashihamacho. chuo-ku, Tokyo, 103-8461
Tel
03-5623-8501
Takuji_Hayakawa@kagome.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
| 2024 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Search strategy)
Fourteen databases and research registries will be searched. Two searchers fill the roles of search and peer review. FFC database will be searched and omitted related studies will be added to the review. The studies found by other methods will be added.
(Selection and data collection)
It will be conducted based on eligibility criteria independently by two reviewers. Disagreements will be resolved by discussion between the reviewers.
(Risk of bias)
It will be assessed independently by two reviewers using modified check list (13 items) of Cochrane Handbook for interventional trials. Disagreements will be resolved by discussion between the reviewers. The agreement rate and the kappa coefficient will be calculated. Studies with a high risk of bias will not be adopted.
(Indirectness)
It will be evaluated independently by two reviewers.
(Data synthesis)
A meta-analysis will be performed using RevMan only in the absence of heterogeneity. Studies with missing data will be excluded if no data is available by contacting the author. If not suitable for integration, a qualitative assessment will be carried out. Sensitivity analysis will be performed as follows,
1)restricting to randomized controlled parallel-group trials.
2)stratified by presence or absence of stress burden.
3)excluding studies with extremely large sample size.
(Imprecision)
It will be assessed based on the total number of participants.
(Inconsistency)
It will be evaluated by the I square value and statistical test in a meta-analysis. If a meta-analysis cannot be performed, it will be assessed from the percentage of studies that have had a significant effect.
(Publication bias)
It will be assessed from Funnel plot in a meta-analysis. If a meta-analysis cannot be performed, it will be assessed from the reporting status of studies registered in research registries.
There was no approval by IRB as this is a meta-analysis, and the date of IRB is the date of protocol fixation.
Management information
Registered date
| 2023 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059245
