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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028404
Receipt No. R000032511
Scientific Title Psychological stress-reducing effect by single or continual ingestion of gamma-aminobutyric acid (GABA): a systematic review with meta-analysis.
Date of disclosure of the study information 2018/12/31
Last modified on 2019/07/29

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Basic information
Public title Psychological stress-reducing effect by single or continual ingestion of gamma-aminobutyric acid (GABA): a systematic review with meta-analysis.
Acronym Psychological stress-reducing effect by single or continual ingestion of gamma-aminobutyric acid (GABA)
Scientific Title Psychological stress-reducing effect by single or continual ingestion of gamma-aminobutyric acid (GABA): a systematic review with meta-analysis.
Scientific Title:Acronym Psychological stress-reducing effect by single or continual ingestion of gamma-aminobutyric acid (GABA)
Region
Japan

Condition
Condition This study will be restricted to all original articles of healthy adults (people not suffering from any diseases). We will exclude minors, pregnant women, those planning a pregnancy, and lactating women.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this review is to assess psychological stress-reducing effect by single or continual ingestion of GABA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We will evaluate the effect by single or continual ingestion of GABA on brain waves, heart rate variability (HRV) and salivary markers (cortisol, alpha-amylase, chromogranin A (CgA)) reported as assessment indices of psychological stress.
Key secondary outcomes We will evaluate the effect by single or continual ingestion of GABA on biochemical markers (body surface temperature and reaction of the eye pupil towards a flash of light, et al.), physiological markers (blood markers (cortisol and adrenocorticotropic hormone (ACTH), et al.) and salivary markers, et al.) and subjective assessment (the Profile of Mood States (POMS) and visual analogue scale (VAS), et al.) reported as assessment indices of psychological stress.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (Study design)
We will include randomized controlled trials (RCT), quasi randomized controlled trials (qRCT), non-randomized controlled trials (nonRCT), crossover trials, cohort studies, and case-control studies.
We will include scientific papers and reports which give us enough research details.

(A) SR on single ingestion of GABA
(PICO)
Participant:
We will include people not suffering from any diseases. We will exclude minors, pregnant women, those planning a pregnancy, and lactating women.

Intervention:
We define a single ingestion of test food containing GABA as an intervention.
Comparison:
We define ingestion of test food not containing GABA or maintaining daily life as controls.

Outcome measurement:
We will evaluate brain waves, HRV and salivary markers (cortisol, alpha-amylase, CgA) as assessment indices of psychological stress.
The secondary outcomes are biochemical markers (body surface temperature and reaction of the eye pupil towards a flash of light, et al.), physiological markers (blood markers (cortisol and ACTH, et al.) and salivary markers, et al.) and subjective assessment (POMS and VAS, et al.).

(B) SR on continual ingestion of GABA
(PI(E)CO)
Participant:
Same as (A)

Intervention:
We define continual ingestion of test food containing GABA as an intervention.
Comparison 1:
Same as (A)

Exposure:
We define continual ingestion of food containing GABA as an exposure.
Comparison 2:
We define eating no food containing GABA as non-exposure. 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:
Same as (A)

(Language)
Eligibility is not restricted by language.
Key exclusion criteria We will exclude cross-sectional studies because it will be difficult to interpret causal relationships between exposure and outcome. We will also exclude proceedings and unpublished studies.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Aizawa
Organization Kagome Co., Ltd.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Aizawa
Organization Kagome Co., Ltd.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL 0287-36-2935
Homepage URL
Email Koichi_Aizawa@kagome.co.jp

Sponsor
Institute Kagome Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Review Team
Professor Hiroharu Kamioka, Department of Ecological Symbiotic Science, Tokyo University of Agriculture
Dr. Takahiro Yoshizaki, Department of Food and Nutritional Sciences, Toyo University
Ms. Mari Makishi, NARASHINO Media Center for Research & Education, Media Net Center, TOHO University.
Mr. Takuro Inoue, Innovation Division,
Kagome Co., Ltd.
Ms. Tomoka Okame, Innovation Division, Kagome Co., Ltd.
Ms. Ayaka Tsutsumi, Innovation Division, Kagome Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address Nihonbashi-Hamacyo F Tower 3-21-1, Nihonbashi-Hmacyo, Chuo-ku, Tokyo
Tel 03-5623-8501
Email 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
2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 244
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 Main results already published
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
2017 Year 07 Month 27 Day
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
2019 Year 06 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information (Searches)
A hospital librarian (e.g., MM) will search 19 databases for studies from the beginning of each database to the search date.

(Data extraction)
Two authors (e.g., TI and TO, or TI and AT) will independently apply all criteria to the full text of articles that have passed the first eligibility screening. Then they will independently extract data from the included studies and cross-check the data.

(Risk of bias assessment)
In order to ensure that variation is not caused by systematic errors in the study or execution, two authors (e.g., TI and TO, or TI and AT) will independently assess the quality of articles. A full quality appraisal of these papers will be made using modified check list (12 items) of Cochrane Handbook for interventional trials, or modified check list (5 items) of GRADE Handbook for observational trials. We will exclude papers with high risk of bias.

Disagreement and uncertainties will be resolved by discussion with another author (e.g., KA). In addition, we will calculate agreement rate and kappa coefficient.

(Inconsistency evaluation)
We will evaluate inconsistency of evidence according to the value of I square and by a statistical test for heterogeneity of effect estimates in a meta-analysis.

(Imprecision assessment)
We will assess imprecision based on the total number of participants in all included studies.

(Meta-analysis)
Only when we will not find heterogeneity in RCT, qRCT, nonRCT, and crossover trials, TY will conduct a meta-analysis using RevMan 5. If we will find missing data, we will make contact with the author to obtain the data.
We will assess heterogeneity according to the value of I square in Forest plot and assess publication bias using Funnel plot.
We will conduct subgroup analyses:
i) restricting to randomized controlled parallel-group trials.
ii) restricting to people burdened with stress-inducing task or not.
iii) excluding trials whose sample sizes are predominantly large compared with the other trials.

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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