UMIN-CTR Clinical Trial

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
Email	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
Email	uemac@kamejikomi.com

Sponsor
Institute	Medical Corporation Kenshokai
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041581