UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063102 |
|---|---|
| Receipt number | R000072222 |
| Scientific Title | An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/29 18:43:25 |
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Basic information
Public title
An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption
Acronym
An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption
Scientific Title
An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption
Scientific Title:Acronym
An Exploratory Study on Individual Differences in Biological Responses to Alcohol Consumption
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the detection accuracy of digital biomarkers related to alcohol consumption has reached a practical level, while exploring the feasibility of classifying patterns of individual variation, thereby contributing to the development of future behavior-change feedback services.
Basic objectives2
Others
Basic objectives -Others
A wristwatch-style wearable sensor capable of non-invasive, long-term continuous monitoring will be used.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of Digital Biomarkers for Alcohol Consumption in Detecting Vital Sign Fluctuations on the Day After Drinking
Key secondary outcomes
Alcohol Consumption and Lifestyle Survey,Biometric data collected by wearable devices,Digital Biomarkers for Alcohol Consumption,Satisfaction Survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
fitness tracker
Interventions/Control_2
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 and Female
Key inclusion criteria
1.Japanese men aged 20 to 59 at the time of obtaining web consent.
2.Subjects who regularly consume alcohol at least once a week.
3.Subjects who can wear a wearable device every day during the observation period, including while sleeping.
4.Subjects who own a smartphone capable of installing applications for wearable devices and who can agree to the terms of use for the wearable devices and applications used in this study.
5.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study.
Key exclusion criteria
1.Subjects who use devices, such as pacemakers, or medications that may affect their heart rate.
2.Subjects who are taking medication or under medical treatment.
3.Subjects who are under exercise therapy or dietetic therapy.
4.Subjects with conditions such as eczema, allergies, or sensitive skin that may cause dermatitis or other skin problems when wearing a wearable device.
5.Subjects with a current or past history of drug or alcohol dependence.
6.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
7.Subjects who are currently pregnant or breastfeeding, or who may become pregnant or start breastfeeding during the study period.
8.Subjects who have difficulty recording their alcohol consumption and lifestyle habits as required by the Alcohol Consumption and Lifestyle Questionnaire.
8. Subjects who have difficulty complying with recording information on alcohol consumption and lifestyle questionnaires.
9.In addition, subjects whom the head of a research institution, a contract research organization, or a joint research organization determines to be unsuitable for participation in the relevant study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakano |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Frontier Science Research Institute
Zip code
302-0106
Address
1-1-21 Midori, Moriya City, Ibaraki Prefecture, 302-0106, Japan
TEL
0297-46-1111
yousuke.nakano@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
MIS Co.,Ltd.
Division name
Clinical Development Department
Zip code
531-0072
Address
8F,Sho-rei Building, 3-4-14 Toyosaki, Kitaku, Osaka-Shi, Osaka, 531-0072, Japan
TEL
06-7878-6780
Homepage URL
mis_21@mis21.co.jp
Sponsor or person
Institute
MIS Co.,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
DiaStep Medical Corporation Home Doctor Clinical Research Ethics Review
Address
3F, Morizumi Building, 22-7 Taishido 4-chome, Setagaya-ku, Tokyo
Tel
03-5433-3255
tomohisa.kato@diastep.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
| 2026 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072222
