UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048313 |
|---|---|
| Receipt number | R000055058 |
| Scientific Title | Evaluation of effects of alcohol |
| Date of disclosure of the study information | 2022/07/08 |
| Last modified on | 2023/01/06 10:54:18 |
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Basic information
Public title
Evaluation of social effects of alcohol
Acronym
Evaluation of social effects of alcohol
Scientific Title
Evaluation of effects of alcohol
Scientific Title:Acronym
Evaluation of effects of alcohol
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the social effects of alcohol in humans, the study on the subjective assessment of psychological impact and objective assessment to support the subjective assessment will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Amount of coversation
* Facial expression
Key secondary outcomes
* Questionnaires to assess the psychological impact
* Physiological indicators that support psychology
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food will be ingested over a period of 15 minutes.
Interventions/Control_2
Study food will be ingested over a period of 15 minutes.
Interventions/Control_3
Study food will not be ingested.
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Aged 20 to under 35 at the time of informed consent.
2. Japanese male and female
3. Those who drink alcoholic beverages at least once a week
4. Those who can drink 350ml of highball with 7% alcohol in 15 minutes without difficulty.
5. Those who drink highball more than one day a month
6. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. Those who have history of alcoholism or other mental or neurological problems
2. Those who has a problem with wearing heart rate meters
3. Those who has difficulty abstaining from alcohol starting from one day prior to the start of the study
4. Those who is unable to drink alcohol constitutionally
5. Judged by the investigator to be unsuitable for participating in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | IBARAKI |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.
Division name
Neuro Innovation Unit
Zip code
102-0093
Address
JA KYOSAI Bldg, 10th Fl., 7-9,Hirakawacho 2-chome, Chiyoda-ku, Tokyo, Japan
TEL
03-6261-4526
ibarakit@nttdata-strategy.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | NAGAOKA |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.
Division name
Neuro Innovation Unit
Zip code
102-0093
Address
JA KYOSAI Bldg, 10th Fl., 7-9,Hirakawacho 2-chome, Chiyoda-ku, Tokyo, Japan
TEL
03-6261-4526
Homepage URL
nagaokaa@nttdata-strategy.com
Sponsor or person
Institute
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2022 | Year | 07 | Month | 08 | 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 | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055058
