UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052709 |
|---|---|
| Receipt number | R000060146 |
| Scientific Title | Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2025/05/12 13:14:47 |
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Basic information
Public title
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Acronym
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Scientific Title
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Scientific Title:Acronym
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Region
| Japan |
Condition
Condition
Excessive drinking that increases the risk of lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a study investigating the impact of non-alcoholic beverage provision on alcohol consumption levels and identify the various factors that influence drinking behaviors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total alcohol intake for past 3 weeks from baseline (3 weeks after intervention)
Key secondary outcomes
Correlation Between Non-Alcoholic and Alcoholic Beverage Consumption, Total Alcohol Intake, Heavy Drinking Days, Heavy Episodic Drinking, and Binge Drinking Patterns Over Three Weeks
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Provision of non-alcoholic beverages for 3 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Drinkers who drink four days or more a week
2.Drinkers who drink 40g or more for men, 20g or more for women per day
Key exclusion criteria
1.Pregnant / lactating
2.Alcohol dependence syndrome
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba 305-8550
TEL
029-853-1019
hisashiyoshi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Ohata |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba
TEL
029-853-1019
Homepage URL
lifestyle-tsukuba@un.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, R&D Center for Lifestyle Innovation
Institute
Department
Personal name
Funding Source
Organization
ASAHI BREWERIES, 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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba 305-8575
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2023 | Year | 12 | Month | 31 | 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
| Delay expected |
Results Delay Reason
under review
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
Suspended
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060146
