UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045190 |
|---|---|
| Receipt number | R000051625 |
| Scientific Title | Evaluation of the effect of the speed of taking alcohol on physiological changes and feeling drunkenness -a randomized, open, crossover study- |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/05/17 10:51:35 |
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Basic information
Public title
Evaluation of the effect of the speed of taking alcohol on physiological changes and feeling drunkenness
-a randomized, open, crossover study-
Acronym
Evaluation of the effect of the speed of taking alcohol on physiological changes and feeling drunkenness
-a randomized, open, crossover study-
Scientific Title
Evaluation of the effect of the speed of taking alcohol on physiological changes and feeling drunkenness
-a randomized, open, crossover study-
Scientific Title:Acronym
Evaluation of the effect of the speed of taking alcohol on physiological changes and feeling drunkenness
-a randomized, open, crossover study-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the speed of taking alcohol on physiological changes and subjective feeling drunkenness.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood alcohol concentration and breath alcohol concentration
Key secondary outcomes
Subjective feeling of drunkenness (VAS score).
Acetic acid, lactic acid, pyruvate, neutral fat, uric acid, blood glucose.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink 480 mL alcoholic beverage in 120 min.
Interventions/Control_2
Drink 480 mL alcoholic beverage in 60 min.
Interventions/Control_3
Drink 480 mL alcoholic beverage in 30 min.
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 male and female adults aged 20 to 64 years old.
Key exclusion criteria
1) Those who cannot drink specified amount alcohol.
2) Those who are hepatitis B antigen test positive.
3) Those who performed blood component donation or 200 mL blood donation in past one month before this trial started.
4) Male who performed 400 mL whole blood donation in past 3 months before this trial started, or female who performed 400 mL whole blood donation in past 4 months before this trial started.
5) Those who are judged not to be appropriate as the subjects in this trial by the investigator.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Nakamura |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Laboratories, Director
Zip code
302-0106
Address
1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL
0297-46-1671
yasunori.nakamura@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Oshima |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Laboratories, Project manager
Zip code
302-0106
Address
1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL
0297-46-1671
Homepage URL
shunji.oshima@asahi-qi.co.jp
Sponsor or person
Institute
Asahi Quality & Innovations, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 10 | Month | 01 | 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
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051625
