UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056134 |
|---|---|
| Receipt number | R000064135 |
| Scientific Title | Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism and Feelings the Morning after Drinking |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/13 19:14:59 |
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Basic information
Public title
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism and Feelings the Morning after Drinking
Acronym
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism and Feelings the Morning after Drinking
Scientific Title
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism and Feelings the Morning after Drinking
Scientific Title:Acronym
Study on the Effects of Foods Containing Amino Acids on Ethanol Metabolism and Feelings the Morning after Drinking
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 and improves the next morning's feelings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breath ethanol concentration
VAS scores the morning after alcohol consumption
Key secondary outcomes
Symptoms of Drunkenness
Oguri-Shirakawa-Azumi sleep inventory MA version (OSA-MA) scores the morning after alcohol consumption
Data on Sleep
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food (Single intake)
Interventions/Control_2
Test food 1 (Single intake)
Interventions/Control_3
Test food 2 (Single 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
| Not applicable |
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) Persons 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) Persons taking drugs or receiving medication related to liver function.
2) Persons with a history of serious diseases of the digestive organs, liver, kidneys, etc.
3) Persons 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 or insomnia.
5) Persons who habitually consume foods or medicines that may affect test results, such as amino acids (amino acid preparations, foods, beverages, etc.), alcohol care-related foods, etc.
6) Persons who are determined to be unable to drink alcohol as a result of an alcohol constitution test.
7) Pregnant, possibly pregnant, or lactating.
8) Persons judged by the principal investigator to be inappropriate as research subjects.
Target sample size
30
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 | Michihide |
| Middle name | |
| Last name | Uo |
Organization
Ajinomoto Co., Inc.
Division name
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
080-2160-0048
Homepage URL
michihide.uo.3v5@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
| 2024 | Year | 11 | Month | 14 | 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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 14 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064135
