UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057752 |
|---|---|
| Receipt number | R000065999 |
| Scientific Title | A study on the influence of dietary fiber on breath alcohol concentration |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/05/01 16:19:43 |
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Basic information
Public title
A study on the influence of dietary fiber on breath alcohol concentration
Acronym
A study on the influence of dietary fiber on breath alcohol concentration
Scientific Title
A study on the influence of dietary fiber on breath alcohol concentration
Scientific Title:Acronym
A study on the influence of dietary fiber on breath alcohol concentration
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of consumption of the test food while drinking on breath alcohol concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the breath alcohol concentration curve
Key secondary outcomes
A questionnaire on the subjective scores for flush reaction
A questionnaire on the subjective scores for drunkenness symptoms
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
4
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
Test food 3 (Single intake)
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy men who are 20 years of age to 49 years of age at the time consent is obtained and work at the Utajima office of Ezaki Glico Co., Ltd.
2. Subjects whose BMI is 18.5 kg/m^2 or more and less than 25.0 kg/m^2
3. Subjects who usually eat three meals a day on a regular basis.
4. Subjects who could stop drinking alcohol from one day prior to the test.
5. Subjects who, after receiving a sufficient explanation of the research participation, fully understand it and consent to participate in the research in writing.
Key exclusion criteria
1. Subjects who are unable to consume alcohol due to their constitution and have difficulty consuming about 25 g of pure alcohol on an empty stomach.
2. Subjects who may drive a car, bicycle, or operate machinery that is prohibited to be operated after drinking alcohol on the day of or the morning of the following day that they drank alcohol for the clinical test.
3. Subjects currently suffering from any illness and receiving drug treatment.
4. Subjects with a history or current medical history of serious disorders of the digestive organs, liver, kidneys, heart, lungs, blood, etc.
5. Subjects who may develop allergic symptoms to the test food, or those who may develop serious allergic symptoms to other foods or medicines.
6. Subjects who may change their lifestyle during the test period (long trips, etc.)
7. Subjects with arrhythmia.
8. Subjects participating in another clinical trial that involves the consumption of other foods or drugs.
9. Subjects with a BMI of less than 18.5 kg/m^2 or a BMI of 25.0 kg/m^2 or higher
10. Subjects with a habit of excessive drinking (Subjects who drink alcohol every day, and whose average daily alcohol intake exceeds 40 g of pure alcohol).
11. Subjects who regularly use supplements or drinks (such as turmeric) that can affect drunkenness or hangovers
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Nakanishi |
Organization
Ezaki Glico Co., Ltd.
Division name
Nutritious Confectionery Supplement Business Division
Zip code
555-8502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka-shi, Osaka, Japan
TEL
080-8519-1271
yasuaki.nakanishi@glico.com
Public contact
Name of contact person
| 1st name | Hiromori |
| Middle name | |
| Last name | Nemoto |
Organization
Ezaki Glico Co., Ltd.
Division name
Nutritious Confectionery Supplement Business Division
Zip code
555-8502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka-shi, Osaka, Japan
TEL
050-1746-2607
Homepage URL
hiromori.nemoto@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka-shi, Osaka, Japan
Tel
06-6477-8352
kazunori.nishi@glico.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
江崎グリコ株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | 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 | 02 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065999
