UMIN-CTR Clinical Trial

Public title

Blood pressure-lowering effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review with meta-analysis

Acronym

Blood pressure-lowering effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review

Scientific Title

Blood pressure-lowering effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review with meta-analysis

Scientific Title:Acronym

Blood pressure-lowering effect of oral intake of gamma-aminobutyric acid (GABA): an updated systematic review

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether orally ingested GABA suppress blood pressure in healthy adults

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Systolic blood pressure, diastolic blood pressure

Key secondary outcomes

None

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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) and include grade I hypertensive adults (in addition to adults with normal and high-normal blood pressure).

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:
Systolic blood pressure, diastolic blood pressure

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 ]and include grade I hypertensive adults (in addition to adults with normal and high-normal blood pressure).

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:
Systolic blood pressure and diastolic blood pressure

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

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

Email

Shingo_Takahashi@kagome.co.jp

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

Email

g167_0@kagome.co.jp

Institute

KAGOME CO., LTD.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kagome CO.,LTD. Research Ethics Review Committee

Address

3-21-1 Nihonbashihamacho. chuo-ku, Tokyo, 103-8461

Tel

03-5623-8501

Email

Takuji_Hayakawa@kagome.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

791

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

07

Month

25

Day

Date of IRB

2023

Year

07

Month

25

Day

Anticipated trial start date

2023

Year

07

Month

31

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 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) stratified by normal blood pressure, high-normal blood pressure, normal + high-normal blood pressure, and grade I hypertension.
2) restricting to randomized controlled parallel-group trials.

(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.

(Review team)
KY, SS, ST (KAGOME), HK, MM, SS (Others)

Registered date

2023

Year

07

Month

28

Day

Last modified on

2024

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059053