UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059472 |
|---|---|
| Receipt number | R000068024 |
| Scientific Title | Observational study of the association between alcohol consumption and biological data in daily life |
| Date of disclosure of the study information | 2025/10/20 |
| Last modified on | 2025/10/20 17:18:35 |
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Basic information
Public title
Observational study of the association between alcohol consumption and biological data in daily life
Acronym
Observational study of the association between alcohol consumption and biological data in daily life
Scientific Title
Observational study of the association between alcohol consumption and biological data in daily life
Scientific Title:Acronym
Observational study of the association between alcohol consumption and biological data in daily life
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will be conducted to examine the association between alcohol consumption and biological data in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physiological measurements using a wearable device
Key secondary outcomes
Questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Adults aged 20 years or older and under 40 years
(2) Male and female working adults
(3) BMI less than 30.0
(4) Non-smokers (no smoking within the past year)
(5) Individuals who have a habitual alcohol consumption in their daily life
(6) Users of an iPhone with iOS 16 or later, or an Android device with OS 10 or later
(7) Individuals who have sufficient understanding of the purpose and details of this study, have the capacity to give consent, and can provide their own consent via electronic informed consent after receiving an adequate explanation
Key exclusion criteria
(1) Individuals currently receiving treatment with any medication or herbal medicine (occasional use allowed).
(2) Individuals with a history or current diagnosis of serious diseases affecting the heart, liver, kidneys, digestive system, or other major organs.
(3) Individuals with hay fever (autumn pollen) or allergic rhinitis (seasonal or perennial).
(4) Individuals under dietary or exercise therapy supervised by a physician.
(5) Individuals who routinely use over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, Foods with Function Claims, or supplements that may affect the autonomic nervous system, metabolism, or sleep (those who can stop use after consent and during the study may participate).
(6) Individuals consuming excessive alcohol (60 g or more pure alcohol per day).
(7) Individuals with extremely irregular eating habits or lifestyles, such as shift or night workers.
(8) Individuals who participated in another clinical trial within one month before consent (except for psychological studies under the AQI), those currently or planning to participate during this study, or within four weeks after its completion.
(9) Individuals who have experienced major life stress (for example, relocation, job change, or bereavement) within three months before consent, or are expected to during the study.
(10) Individuals with known drug or food allergies.
(11) Individuals unable to consume alcohol due to intolerance.
(12) Individuals who are pregnant, lactating, possibly pregnant, or planning pregnancy during the study.
(13) Individuals unable to wear a wrist type wearable device daily.
(14) Individuals judged unsuitable for participation by the principal investigator.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirota |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-21, Midori 1-chome, Moriya-shi, Ibaraki, Japan
TEL
0297-46-4064
tatsuhiko.hirota@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
080-5186-5400
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 10 | Month | 20 | 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
| 2025 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068024
