UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060227 |
|---|---|
| Receipt number | R000068859 |
| Scientific Title | Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/25 15:54:23 |
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Basic information
Public title
Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals
Acronym
Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals
Scientific Title
Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals
Scientific Title:Acronym
Study on Blood Glucose Changes During Daily Alcohol Consumption and Snacking in Healthy Individuals
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to understand the factors influencing blood glucose changes caused by daily alcohol consumption and snacking.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose changes
Key secondary outcomes
Record Log, Questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)Toshiba corporate cohort registrants who have provided consent to participate in this study
2)Male individuals aged 35 or older but under 60 at the start of the study
3)Individuals who drink alcohol 2 to 5 times per week
4)Individuals whose single drinking session contains 20g or more of alcohol
5)Individuals with no smoking habit
6)Healthy individuals not undergoing regular medical treatment or taking medication
7)Individuals who have never experienced skin issues (such as rashes, eczema, redness) from using cosmetics or quasi-drugs and do not consider their skin sensitive
8)Individuals able to wear Libre 2 for approximately 2 weeks (maximum 14 days) and maintain a log regarding alcohol consumption, complete a hangover questionnaire, and record snacking and hunger levels
9)Individuals employed at Toshiba headquarters at the study start date who can come to a designated location at Toshiba headquarters during non-working hours (lunch break) for Libre 2 application and data retrieval completion
10)Individuals who can comply with the Libre 2 service regulations and instruction manual contents
11)Individuals who can personally prepare a smartphone (iPhone or Android) meeting the requirements for FreeStyle Libre Link compatibility
12)Individuals with no scheduled MRI, X-ray, or CT scans during the Libre wear period
13)Individuals with no scheduled airplane travel during the Libre wear period
Key exclusion criteria
1)Individuals who may change their lifestyle habits during the study period
2)Individuals who participated in another clinical trial involving interventions within one month prior to registering their consent to participate in this study, or who plan to participate in another clinical trial involving interventions during the study period
3)Individuals who currently have, or have had within the past three months, a habit of continuously consuming foods with functional claims, health foods, or supplements that claim to affect blood glucose levels, or who plan to consume such products during the study period
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Uchida |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
h-uchida-ji@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & Co., Ltd.
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
Toshiba Corporation, Corporate Technology Planning Div., Life Science Business Ethics Review Board
Address
72-34,Horikawa-cho,Saiwai-ku,Kawasaki-shi,Kanagawa
Tel
044-578-8414
masatoshi.sakurai.n10@mail.toshiba
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
| 2025 | Year | 12 | Month | 29 | 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 | 21 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to understand the factors influencing blood glucose changes caused by daily alcohol consumption and snacking.
Management information
Registered date
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068859
