UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044158 |
|---|---|
| Receipt number | R000050072 |
| Scientific Title | A confirmation study of test food in alcohol metabolism |
| Date of disclosure of the study information | 2021/07/16 |
| Last modified on | 2021/08/06 08:01:12 |
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Basic information
Public title
A confirmation study of test food in alcohol metabolism
Acronym
A confirmation study of test food in alcohol metabolism
Scientific Title
A confirmation study of test food in alcohol metabolism
Scientific Title:Acronym
A confirmation study of test food in alcohol metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify test food on sobering up, related to amelioration of alcohol metabolism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood acetaldehyde concentration.
Key secondary outcomes
Blood ethanol concentration,Breath ethanol
concentration,VAS questionnaire about
drinking and sense,Blood glucose
concentration.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food- washout period- single ingestion of placebo food.
Interventions/Control_2
Single ingestion of placebo food- washout period- single ingestion of test food.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged over 20 to under 65 when informed consent.
(2)Subjects who can take 25g of alcohol on an empty stomach. (approximate amount: 1 large bottle of beer (633mL), 1.3 go of sake)
(3)Subjects who can drink 125 mL of shochu with 25% alcohol by on the rocks.
(4)Subjects who can tolerate repeated blood sampling.
(5)Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
Key exclusion criteria
(1)Subjects infected by hepatitis virus.
Subjects who...
(2) had or suspected infectious disease such as COVID-19, or who had close contact with a patient.
(3) cannot drink alcohol at all.
(4) showed strong positive reaction in patch test of alcohol.
(5)Subjects are aware of losing control due to drinking alcohol (entanglement, anger, yelling,etc.)
(6) intake excessive alcohol. (Those who daily consume average more than about 60g of pure alcohol)
(7)Who weigh 45 kg > or 90 kg <.
(8)have current medical history or past medical history of diabetes.(9)constantly use medicines that may affect test results.Those who taking health foods and supplements daily, and those who may take or take them during the test period.(10)have current medical history or past medical history of serious disease in heart, liver, kidney, digestive organ.(11)are planning some kind of treatment during the study period.
(12)Females who are pregnant or could become pregnant, and who are lactating.(13)Subjects who have medicine, milk or gelatin allergy.
Subjects who
(14)participated clinical trial within 4 weeks prior to the current study and/or who have planning to participate other clinical tests.(15)donated over 200mL blood and/or blood components within the last one month to the current study.
(16)Males who donated over 400mL blood and/or blood components within the last 3 mos. to the current study.(17)Females who donated over 400mL blood and/or blood components within the last 4 mos. to the current study.(18)Males who exceed 1200 mL of blood when the planned total blood sampling volume of the study is added to the blood sampling volume from 12 mos. before the start of the study.(19)Females who exceed 800 mL of blood when the planned total blood sampling volume of the study is added to the blood sampling volume from 12 mos. before the start of the study.(20)Subjects who were judged ineligible for enrollment in the study by the principal investigator or sub-investigator.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co.,Ltd
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
070-3821-8134
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inagaki |
Organization
Morinaga & Co.,Ltd
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
070-3864-8665
Homepage URL
h-inagaki-jj@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2021 | Year | 07 | Month | 16 | 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
Paper submission in progress.
Results date posted
| 2021 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Blood acetaldehyde, ethanol and glucose levels,
Exhaled ethanol levels.
Visual analog scale (VAS) scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050072
