UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056362 |
|---|---|
| Receipt number | R000064303 |
| Scientific Title | Effect of Alcohol Consumption and Drinking-Related Outcomes to take vinegar drinks or mineral water: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2025/04/21 14:32:01 |
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Basic information
Public title
Effect of Alcohol Consumption and Drinking-Related Outcomes to take vinegar drinks or mineral water: A Pilot Randomized Controlled Trial
Acronym
Effect of Alcohol Consumption and Drinking-Related Outcomes to take vinegar drinks or mineral water: A Pilot Randomized Controlled Trial
Scientific Title
Effect of Alcohol Consumption and Drinking-Related Outcomes to take vinegar drinks or mineral water: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Effect of Alcohol Consumption and Drinking-Related Outcomes to take vinegar drinks or mineral water: A Pilot Randomized Controlled Trial
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
Assess the impact of taking vinegar drinks and mineral water on alcohol consumption and drinking-related outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in total alcohol intake from baseline
Key secondary outcomes
1) Days of the consumption of pure alcohol intake of 60g or more
2) Subjective health perception
3) Modified Fatigue Impact Scale
4) K6
5) The Short Warwick-Edinburgh Mental Wellbeing Scale
6) Satisfaction With Life Scale
7) Pittsburg Sleep Quality Index
8) physical and mental symptoms of Anti-Aging QOL Common Questionnaire: AAQol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Vinegar Drink 100ml/day for 4 weeks
Interventions/Control_2
mineral water 100ml/day for 4 weeks
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) 20 years and over
2) Drinkers who drink four days or more a week
3) Drinkers whose average consumption of pure alcohol intake of 40g or more for male, 20g or more for female per day
Key exclusion criteria
1) Disagreement with this study
2) No decision making ability
3) Those who have a history of taking vinegar drinks over 4 times per month
4) Pregnant/lactating
5) 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, Ibaraki 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, Ibaraki 305-8550
TEL
029-853-1019
Homepage URL
lifestyle-tsukuba@un.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Yoshimoto Hisashi
Funding Source
Organization
Mizkan Holdings 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
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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 04 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064303
