UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036493 |
|---|---|
| Receipt number | R000041581 |
| Scientific Title | Verification test of the effectiveness to alcohol metabolism by the intake of the beverage containing moromi lactic acid fermented |
| Date of disclosure of the study information | 2019/04/13 |
| Last modified on | 2021/04/16 10:33:35 |
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Basic information
Public title
Verification test of the effectiveness to alcohol metabolism by the intake of the beverage containing moromi lactic acid fermented
Acronym
alcohol metabolism by the intake of the beverage containing moromi lactic acid fermented
Scientific Title
Verification test of the effectiveness to alcohol metabolism by the intake of the beverage containing moromi lactic acid fermented
Scientific Title:Acronym
alcohol metabolism by the intake of the beverage containing moromi lactic acid fermented
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to confirm the effectiveness of promoting the alcohol metabolism expected of moromi vinegar lactic acid fermentate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood ethanol, Blood Acetaldehyde
Key secondary outcomes
expiration ethanol
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Moromi lactic acid fermented product containing beverage
Interventions/Control_2
Placebo beverage
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Adult male at the age of 20 to 60 at the time of obtaining consent
(2) Person who can drink diluted awamori (Alcohol content less than about 30%)
(3) Person who was judged as "thin erythema" or "no erythema" by alcohol patch test
(4) Person who weighs 50.0 kg to 90.0 kg
(5) Persons with physique index (BMI) of 18.5 to 29.9 at the time of obtaining consent
(6) Persons who are judged to have no problem in participation in this study
(7) Persons who obtain written consent to participate in the trial
Key exclusion criteria
1) Person who can not drink
(2) Intakes of food and health food that are described as containing ingredients related to the test food: Moromi vinegar
(3) Those who regularly use medicines, health food, food for specified health use, food with functional indication that may affect liver function
(4) Those who regularly take health supplements and supplements related to immune function
(5) Night shift workers and shift workers
(6) At the time of obtaining consent, those who receive treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at medical institutions etc. for treatment or prevention of disease etc. or conditions that require treatment Person to be judged
(7) A person who is deemed to be inappropriate for the study participation
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kondo |
| Middle name | |
| Last name | Sumio |
Organization
Medical Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
2-12-13, Tamagawa Fukushima-ku, Osaka, Japan
TEL
06-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Uema |
| Middle name | |
| Last name | Tyoryo |
Organization
ISHIKAWA SHUZOJO Co. Ltd.
Division name
Production department
Zip code
903-0103
Address
Onaha 1438-1, Nishihara Town, Nakagami-Gun, Okinawa, Japan
TEL
098-945-3515
Homepage URL
uemac@kamejikomi.com
Sponsor or person
Institute
Medical Corporation Kenshokai
Institute
Department
Personal name
Funding Source
Organization
ISHIKAWA SHUZOJO Co. Ltd.
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
Brain Care Clinic Ethics Review Committee
Address
Samon-Cho13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel
03-3351-3386
yuyosei@drc-web.co.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
| 2019 | Year | 04 | Month | 13 | 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
| Delay expected |
Results Delay Reason
Delay Statics Analysis
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
| 2019 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041581
| 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 |
