UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055245 |
|---|---|
| Receipt number | R000063129 |
| Scientific Title | Research on the relationship between alcohol consumption and happiness among ADH1B and ALDH2 genotypes. |
| Date of disclosure of the study information | 2024/08/15 |
| Last modified on | 2024/08/15 06:03:57 |
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Basic information
Public title
Research on the relationship between alcohol consumption and happiness among ADH1B and ALDH2 genotypes.
Acronym
Research on the relationship between alcohol consumption and happiness among ADH1B and ALDH2 genotypes.
Scientific Title
Research on the relationship between alcohol consumption and happiness among ADH1B and ALDH2 genotypes.
Scientific Title:Acronym
Research on the relationship between alcohol consumption and happiness among ADH1B and ALDH2 genotypes.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Clarify the relationship between alcohol consumption and happiness according to the ADH1B and ALDH2 genotypes.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between drinking habit and happiness based on the ADH1B and ALDH2 genotypes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADH1B and ALDH2 genotypes, Drinking habits, Subjective happiness
Key secondary outcomes
Analysis of SNPs (single nucleotide polymorphisms) in ADH1B and ALDH2, subjective evaluation questionnaire (drinking habits, level of happiness)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Recruitment targeting employees of the research facility and residents in the vicinity of Beppu City
1) who have provided written consent voluntarily.
2) aged 20 and above but below 65 at the time of consent acquisition, regardless of gender.
3) who have not been diagnosed with chronic illnesses.
Key exclusion criteria
1) who are pregnant, breastfeeding, or intend to become pregnant during the test period.
2) who are expected to undergo significant changes in their living environment, such as moving or job relocation, during the test period.
3) with a history of and current serious illnesses in the heart, liver, kidneys, digestive system, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Managi |
Organization
Kyushu University
Division name
Urban Institute
Zip code
819-0395
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
TEL
092-802-3401
managi.s@gmail.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Takeda |
Organization
Kyushu University
Division name
Urban Institute
Zip code
819-0395
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
TEL
092-802-3401
Homepage URL
takeda.midori.102@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Sanwa Shurui Co.,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
Urban Institute Research Ethics Committee
Address
#1036 West2, 744 Motooka, Nishi-ku, Fukuoka-Shi, Fukuoka
Tel
092-802-3401
takeda.midori.102@m.kyushu-u.ac.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
| 2024 | Year | 08 | Month | 15 | 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
189
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
| 2023 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Data will be collected on the ADH1B and ALDH2 genotypes, and questionnaire, and the association will be analyzed.
Management information
Registered date
| 2024 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063129
