UMIN-CTR Clinical Trial

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
Email	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
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

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
Email	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	Preinitiation
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	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054072

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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