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UMIN-CTR Clinical Trial |
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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 |
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- |
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Scientific Title:Acronym | Safety evaluation of overdose intake of Fermented barley GABA 90 %.
-Placebo-controlled, double-blind, randomized, parallel-group comparative study- |
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Region |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 48 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | Preinitiation | ||||||
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=R000054072 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |