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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048424
Receipt No. R000055187
Scientific Title A study to confirm the blood dynamics by a single ingestion of GABA-containing foods in healthy humans.
Date of disclosure of the study information 2022/08/03
Last modified on 2022/07/21

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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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