UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060421 |
|---|---|
| Receipt number | R000069118 |
| Scientific Title | Alcohol absorption inhibitory effect confirmation test by food intake |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 11:59:41 |
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Basic information
Public title
Alcohol absorption inhibitory effect confirmation test by food intake
Acronym
Alcohol absorption inhibitory effect confirmation test by food intake
Scientific Title
Alcohol absorption inhibitory effect confirmation test by food intake
Scientific Title:Acronym
Alcohol absorption inhibitory effect confirmation test by food intake
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether consuming food 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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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 food 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese males aged 30 to 59 years
2) Subjects who drink alcohol 3 or more times a week
3) Subjects who can drink a prescribed amount of alcohol
4) Subjects with a BMI between 18.5 and 30.0
Key exclusion criteria
1) Subjects who have been diagnosed with liver dysfunction by a medical checkup
2) Subjects taking drugs related to liver function
3) Subjects undergoing regular medical treatment
4) Subjects with a history of serious diseases of the digestive organs, liver, kidneys, etc.
5) Subjects who regularly ingest health food or medicine that affects liver function
6) Subjects having drug and food allergy
7) Subjects who have participated in other clinical study within one month before the study or plan to participate in other clinical study after informed consent to the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Oe |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo, Japan
TEL
0353847759
mariko_oe@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo, Japan
TEL
0353847759
Homepage URL
yoshimi_bansho@kewpie.co.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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 01 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069118
