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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047414
Receipt No. 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 2022/04/06

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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
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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