UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049869 |
|---|---|
| Receipt number | R000056799 |
| Scientific Title | A confirmation study of test food in alcohol metabolism |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2023/08/23 09:07:07 |
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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 subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify effects of test foods on alcohol metabolism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood ethanol concentration, Blood acetaldehyde concentration Expiration ethanol concentration, one-leg standing time with eyes closed.
Key secondary outcomes
Blood glucose concentration, VAS questionnaire about drinking and sense.
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
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 0.5g/kg (ideal body weight) of alcohol(25% alcohol by shochu) when stomach empty. Approximate amount is 117 mL to 138 mL for women of155 cm to 165 cm height, and 146 mL to 169 mL for men of 165 cm to 175 cm height.
(3)Subjects who can drink approximate 13% alcohol.
(4)Subjects who have a habit of spontaneous alcohol consumption at least twice a week and are aware frequent redness of the face, neck, etc.
(5)Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
Key exclusion criteria
Subjects who
(1)infected by hepatitis virus.
(2)had or suspected infectious disease such as COVID-19, or who had close contact with a COVID-19 patient.
(3)cannot drink alcohol at all.
(4)showed strong positive reaction in patch test of alcohol.
(5)aware of losing control due to drinking alcohol (entanglement, anger, yelling, crying, etc.)
(6)intake excessive alcohol. (Those who daily consume average more than about 60g of pure alcohol)
(7)weigh less than 45 kg or more than 90 kg.
(8)have current medical history or past medical history of diabetes.
(9)constantly use medicines that may affect test results. (cephem antibiotics such as Cefaclor, Cefotiam, Cefdinir, Anti-alcoholic drugs such as Disulfiram, Cyanamide etc.).Those taking health foods and supplements (turmeric, ornithine, etc.) 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)have allergies to medicines and foods (especially milk and gelatin).
(14)participated clinical trial within 4-weeks prior to the current study and/or who have planning to participate the 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 three months to the current study.
(17)Females who donated over 400mL blood and/or blood components within the last four months to the current study.
(18)Males who exceed 1200 mL of blood sampling volume including this study within the last 12 months.
(19)Females who exceed 800 mL of blood sampling volume including this study within the last 12 months.
(20)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
R&D Institute Morinaga & Co., Ltd.
Division name
Health Science Research Center
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
0455716140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inagaki |
Organization
R&D Institute Morinaga & Co., Ltd.
Division name
Health Science and Research Center
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
0455716140
Homepage URL
t-kawama-jb@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Chiyoda paramedical care clinic Institutional Review Board
Address
3-3-10 Honngokucyo Nihonbashi Cyuo-ku Tokyo
Tel
0362259005
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
| 2023 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056799
