UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059066 |
|---|---|
| Receipt number | R000067563 |
| Scientific Title | Effect of Acetic Acid Bacteria Containing Food on Alcohol Absorption Inhibition |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/12 09:49:40 |
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Basic information
Public title
Effect of Acetic Acid Bacteria Containing Food on Alcohol Absorption Inhibition
Acronym
Effect of Acetic Acid Bacteria Containing Food on Alcohol Absorption Inhibition
Scientific Title
Effect of Acetic Acid Bacteria Containing Food on Alcohol Absorption Inhibition
Scientific Title:Acronym
Effect of Acetic Acid Bacteria Containing Food on Alcohol Absorption Inhibition
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether consuming acetic acid bacteria and alcoholic beverages simultaneously inhibits the absorption of alcohol into the body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breath ethanol concentration
Key secondary outcomes
Blood ethanol concentration
Questionnaire survey by visual analogue scale (VAS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Alcohol and acetic acid bacteria intake
Interventions/Control_2
Alcohol and placebo intake
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
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adult males aged 20 to 70 years
People who subjectively have a high tolerance for alcohol
Key exclusion criteria
People taking medication or receiving medical treatment
People with a history of serious illness
People who complain of feeling unwell on the day of the test
People with a hangover due to heavy drinking the previous day
People who have participated in other clinical trials within the past month
People who are otherwise deemed inappropriate by the study director
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kagawa Nutrition University
Division name
KNU Nutrition Clinic
Zip code
170-8481
Address
3-24-3, Komagome,Toshima, Tokyo
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
KNU Nutrition Clinic
Zip code
170-8481
Address
3-24-3, Komagome,Toshima, Tokyo
TEL
03-3918-6181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
The Ethical Committee of Kagawa Nutrition University
Address
3-9-21 Chiyoda Sakado Saitama
Tel
049-282-3721
tma211@eiyo.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
| 2025 | Year | 09 | Month | 12 | 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
7
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067563
