UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048424 |
|---|---|
| Receipt number | 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 | 2022/10/24 09:00:59 |
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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
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
urada@yoshindo.co.jp
Sponsor or person
Institute
Shinwayakuhin Co., Ltd.
Institute
Department
Personal name
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
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
9
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
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 14 | 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 | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055187
