UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047414 |
|---|---|
| Receipt number | R000054072 |
| Scientific Title | Safety evaluation of overdose intake of Fermented barley GABA 90 %. -Placebo-controlled, double-blind, randomized, parallel-group comparative study- |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2024/01/23 16:18:50 |
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Basic information
Public title
Safety evaluation of overdose intake of Fermented barley GABA 90 %.
Acronym
Safety evaluation of overdose intake of Fermented barley GABA 90 %.
Scientific Title
Safety evaluation of overdose intake of Fermented barley GABA 90 %.
-Placebo-controlled, double-blind, randomized, parallel-group comparative study-
Scientific Title:Acronym
Safety evaluation of overdose intake of Fermented barley GABA 90 %.
-Placebo-controlled, double-blind, randomized, parallel-group comparative study-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of overdose ingestion of test food for 4 consecutive weeks, using placebo as a control.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse event
Physical test value
Laboratory test values
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 4 consecutive weeks
Interventions/Control_2
Intake of placebo for 4 consecutive weeks
Interventions/Control_3
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 64
(2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria
(1) Subjects with heart, liver, and kidney diseases (including complications of other diseases)
(2) Subjects with a history of cardiovascular disease
(3) Subjects with diabetes
(4) Subjects with diseases currently being treated
(5) Subjects who are allergic to food and drugs
(6) Subjects with anemia symptoms
(7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(8) Subjects who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible)
(9) Subjects who play intense sports and subjects who are on a diet
(10) Subjects with extremely irregular eating habits
(11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(12) Subjects who drink more than 60 g of average daily pure alcohol
(13) Subjects who smoke an average of 21 or more cigarettes a day
(14) Subjects who are participating in or will participate in other clinical trials at the start of this study
(15) Subjects who were vaccinated against infectious diseases such as influenza and COVID-19 within 1 month before SCR
(16) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
0661355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka,
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
0661355200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 15 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054072
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
