UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058891 |
|---|---|
| Receipt number | R000067350 |
| Scientific Title | Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples (Cross-Sectional Study) |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/09/16 17:41:14 |
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Basic information
Public title
Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples
Acronym
Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples
Scientific Title
Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples (Cross-Sectional Study)
Scientific Title:Acronym
Investigation of the Effects of Heavy Drinking Habits via Genetic Analysis of Self-Collected Samples (Cross-Sectional Study)
Region
| Japan |
Condition
Condition
Heavy Drinking Habits -induced cognitive decline
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the effects of heavy drinking by exploring gene expression in neuron cells derived from self-collected nasal swab samples of heavy drinkers and non-drinkers in their 20s.
Basic objectives2
Others
Basic objectives -Others
A Cross-Sectional Study Investigating the Impact of Heavy Drinking Habits
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene expression levels
Key secondary outcomes
-Blood biochemical tests
-AUDIT
-Smoking history
-Exercise habits
-Anxiety and depression symptoms (K6)
-Sleep status (PSQI)
-Correlation between primary and secondary outcomes
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women in their 20s at the time of written consent
2. AUDIT score of 15 or higher, or non-drinkers with an AUDIT score of 0
3. Received sufficient explanation of the study's purpose and content, demonstrated capacity to consent, voluntarily agreed to participate, and provided written consent
Key exclusion criteria
1. Currently receiving medication or outpatient treatment for any serious illness (as-needed medication permitted)
2. Currently receiving treatment for, or with a history of, psychiatric disorders (e.g., depression) or sleep disorders
3. Blood donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to consent
4. History of feeling unwell or experiencing vasovagal reflex during blood collection
5. Difficulty in self-collecting nasal samples using a swab
6. Difficulty complying with survey questionnaire requirements
7. Currently participating in another clinical trial or planning to do so during the study period
8. Deemed unsuitable as a participant by the principal investigator for any other reason
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Hattori |
Organization
Juntendo University
Division name
Department of Neurology, Juntendo University School of Medicine / President's Office
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-2731
nhattori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD 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
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
| 2025 | Year | 11 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-Sectional Study
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067350
