UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062671 |
|---|---|
| Receipt number | R000071749 |
| Scientific Title | Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/24 17:12:05 |
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Basic information
Public title
Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults
Acronym
Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults
Scientific Title
Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults
Scientific Title:Acronym
Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effect of single intake of food containing Salacia reticulata or food containing acetic acid bacteria extract powder before alcohol consumption on promoting alcohol metabolism after drinking in adults aged 20 years and older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on performance at pre-intake or 30 min, 60 min, 90 min after alcohol loading, and the next morning
Key secondary outcomes
Breath ethanol concentration measurement and performance test at pre-intake or 30 min, 60 min, 90 min after alcohol loading, and OSA sleep questionnaire MA version at pre-intake or the next morning
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food A 3 tablets with 150 mL of water (intake of 180 mL of Japanese sake for 10 minutes at 10 minutes after intake)
Interventions/Control_2
Single intake of test food B 3 tablets with 150 mL of water (intake of 180 mL of Japanese sake for 10 minutes at 10 minutes after intake)
Interventions/Control_3
Single intake of test food C 3 tablets with 150 mL of water (intake of 180 mL of Japanese sake for 10 minutes at 10 minutes after intake)
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
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Persons who have daily drinking experience and can drink 180 mL of Japanese sake (15% alcohol) without problem, but are aware of feeling drunk.
3. Japanese persons aged 20 years or older and under 65 years at the time of obtaining consent.
Key exclusion criteria
1. Persons who have chronic diseases and are receiving medical treatment, or who have a history of serious diseases.
2. Persons who have been diagnosed with diabetes.
3. Persons who regularly take medicines or health foods with health claims (specified health foods, foods with function claims, and foods with nutrient function claims) that may affect alcohol metabolism or sleep quality.
4. Persons who are at risk of developing allergies related to the test foods.
5. Persons who drink a large amount of alcohol (equivalent to 60 g or more of alcohol per day: beer about 1500 mL, wine about 540 mL, Japanese sake about 330 mL, or double whisky about 180 mL).
6. Persons who usually consume a large amount of the test foods.
7. Persons who are judged inappropriate as study participants based on their responses to the background survey.
8. Persons who have participated in other clinical studies within 1 month prior to obtaining consent for this study, or who plan to participate in other clinical studies after consenting to this study.
9. Persons who are breastfeeding, pregnant, or planning or hoping to become pregnant during the study period.
10. Persons who are judged inappropriate as study participants by the principal investigator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd
Division name
President and Representative Director
Zip code
470-1192
Address
11-506, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd.
Division name
President and Representative Director
Zip code
470-1192
Address
11-506, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
Biosis Lab Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SYNKEN Co., Ltd. / Profit organization
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 Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2026 | Year | 08 | Month | 24 | 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
| 2026 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071749
