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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Non | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Research food 1
2 nights 3 days Single ingestion |
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Interventions/Control_2 | Research food 2
2 nights 3 days Single ingestion |
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Interventions/Control_3 | Research food 3
2 nights 3 days Single ingestion |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 9 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |