UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060647 |
|---|---|
| Receipt number | R000067973 |
| Scientific Title | Study on the Effects of Foods Containing Amino Acids (Alanine and Ornithine) on Ethanol Metabolism after Alcohol Consumption in Healthy Employees |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/10 17:55:41 |
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Basic information
Public title
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism after Alcohol Consumption
Acronym
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism after Alcohol Consumption
Scientific Title
Study on the Effects of Foods Containing Amino Acids (Alanine and Ornithine) on Ethanol Metabolism after Alcohol Consumption in Healthy Employees
Scientific Title:Acronym
Study on the Effects of Foods Containing Amino Acids (Alanine and Ornithine) on Ethanol Metabolism after Alcohol Consumption in Healthy Employees
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether the intake of foods containing amino acids promotes ethanol metabolism during alcohol consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breath ethanol concentration
Key secondary outcomes
Symptoms of Drunkenness, Feelings the morning after alcohol consumption
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control Food (amino acid - free)
Interventions/Control_2
Test food 1 (amino acid mixture1)
Interventions/Control_3
Test food 2 (amino acid mixture2)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are 20 years of age or older at the time consent is obtained.
2) Individuals who have a drinking habit (4 or more times a month)
3) Individuals who, after receiving a full explanation of the research participation, fully understand it and give written consent of their own free will.
Key exclusion criteria
1) Individuals taking drugs or receiving medication related to liver function.
2) Individuals with a history of serious diseases of the digestive organs, liver, kidneys, etc.
3) Individuals who have been stopped from drinking by a doctor or are aware of problematic behavior due to alcohol consumption.
4) Those with a history of alcoholism.
5) Individuals who habitually consume foods or medicines that may affect test results, such as amino acids (amino acid preparations, foods, beverages, etc.), or alcohol care-related foods, etc., and who cannot stop taking them during the test period.
6) Individuals who answered "cannot drink" to the question about alcohol tolerance in the lifestyle survey.
7) Individuals who were determined to be unable to drink alcohol (DD type) based on the results of the alcohol sensitivity test.
8) Individuals who are pregnant, may be pregnant, or are breastfeeding.
9) Individuals who have been diagnosed with insomnia and are currently undergoing treatment, and those with irregular bedtimes and wake-up times
10) Individuals deemed unsuitable for participation in this study by the principal investigator for other reasons.
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Nishitani |
Organization
Ajinomoto Co., Inc.
Division name
Functional Ingredients Group Wellness Solution Development Center Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-1045-7701
shinobu.nishitani.vx8@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | MIHOKO |
| Middle name | |
| Last name | TSUJI |
Organization
Ajinomoto Co., Inc.
Division name
Functional Ingredients Group Wellness Solution Development Center Institute of Food Sciences and Tec
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
070-4238-4009
Homepage URL
mihoko.tsuji.gz2@asv.ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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 Ajinomoto Co., Inc.
Address
1-15-1, Kyobashi, Chuo-ku, Tokyo
Tel
+81-3-5250-8134
ajinomoto_irb@ajinomoto.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
味の素株式会社（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 10 | 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 | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067973
