UMIN-CTR Clinical Trial

Basic information
Public title	A study to confirm the blood dynamics by a single ingestion of GABA-containing foods in healthy humans.
Acronym	GABA PK study
Scientific Title	A study to confirm the blood dynamics by a single ingestion of GABA-containing foods in healthy humans.
Scientific Title:Acronym	GABA PK study
Region	Japan

Condition
Condition	Non
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	confirm the blood dynamics by ingestion of GABA-containing foods
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood dynamics by ingestion of GABA-containing foods
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Research food 1 2 nights 3 days Single ingestion
Interventions/Control_2	Research food 2 2 nights 3 days Single ingestion
Interventions/Control_3	Research food 3 2 nights 3 days Single ingestion
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	30 years-old >
Gender	Male
Key inclusion criteria	(1) Japanese males aged between 20 and 30 at the time of obtaining consent to participate in the research (2) Those who can attend the research site on the set visit date (3) Those who agree to participate in the research before starting the research and can sign and date the consent document.
Key exclusion criteria	(1) Those who have a serious medical history (2) Those who have chronic medical illness under treatment (3) Those who have a history of gastrointestinal resection surgery (excluding cecum and mild polyp resection) (4) Those who have food allergies related to the food used in the research (5) Heavy drinkers (those with an average daily intake of pure alcohol exceeding 60 g) and excessive smokers (those who smoke more than 20 cigarettes per day) (6) Those whose values at the time of screening test deviate significantly from the normal values (7) Those who are participating in other clinical research or who are planning to participate during the research period (8) Those who may feel sick or feel ill due to repeated blood sampling (9) Those who work from 22:00 to 6:00 (including part-time workers, shift workers, late-night workers, etc.) (10) Those who cannot consume foods whose origin is not specified due to religious reasons (11) Those who are judged by the principal investigator to be inappropriate for participating in this research
Target sample size	9

Research contact person
Name of lead principal investigator	1st name Urada Middle name Last name Yoshiharu
Organization	Shinwayakuhin Co., Ltd.
Division name	Non
Zip code	939-2723
Address	3697-8, Fuchumachi Haginoshima, Toyama-shi, Toyama
TEL	076-465-7735
Email	urada@yoshindo.co.jp

Public contact
Name of contact person	1st name Urada Middle name Last name Yoshiharu
Organization	Shinwayakuhin Co., Ltd.
Division name	Non
Zip code	939-2723
Address	3697-8, Fuchumachi Haginoshima, Toyama-shi, Toyama
TEL	076-465-7735
Homepage URL
Email	urada@yoshindo.co.jp

Sponsor
Institute	Shinwayakuhin Co., Ltd.
Institute
Department

Funding Source
Organization	Non
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	Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Board
Address	61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel	011-881-0111
Email	matsuda@ughp-cpc.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	2022 Year 08 Month 03 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	2022 Year 07 Month 07 Day
Date of IRB	2022 Year 07 Month 14 Day
Anticipated trial start date	2022 Year 07 Month 21 Day
Last follow-up date	2022 Year 08 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 21 Day
Last modified on	2022 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055187

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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