UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062751 |
|---|---|
| Receipt number | R000071846 |
| Scientific Title | Verification of the Effect of the Test Food on Inhibiting the Rise in Blood Glucose Levels. |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 17:18:07 |
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Basic information
Public title
Consumer Survey on the Blood Sugar Raising Effects of Our Company's Cheesecake and Pudding
Acronym
Consumer Survey on the Blood Sugar Raising Effects of Our Company's Cheesecake and Pudding
Scientific Title
Verification of the Effect of the Test Food on Inhibiting the Rise in Blood Glucose Levels.
Scientific Title:Acronym
Verification of the Effect of the Test Food on Inhibiting the Rise in Blood Glucose Levels.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification That Blood Glucose Levels Rise Gradually After Consumption of Our Company's Cheesecake and Pudding
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Glucose Peak, Time to Blood Glucose Peak, Blood Glucose Rise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume the control diet twice a week and each of the four test foods once a week
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged 40 to 59 as of April 1 2026.
2. Individuals who have not been identified as having impaired glucose tolerance in previous tests.
3. People with BMI between 18.5 and 24.9.
4. Individuals who prior to participating in the main study have received an explanation of the study understand its content and agree with its purpose and individuals who can obtain written informed consent from the research participants themselves.
5. Individuals who are not currently consuming or who can maintain the same types and frequency of consumption as they had prior to the study period of foods that may affect blood glucose levels such as products containing resistant dextrin including foods for specified health uses foods with functional claims and dietary supplements.
Key exclusion criteria
1. Subjects with serious cardio vascular, hepatic renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders.
2. Individuals with a fasting blood glucose level of 126 mg/dL or higher, or an HbA1c level of 6.5% or higher.
3. Subjects receiving treatment for a gastrointestinal disease currently or those who have had.
4. Subjects with an allergy to the test food.
5. Individuals who regularly use pharmaceuticals or quasi drugs that affect blood sugar levels, such as those containing vasoconstrictors or licorice.
6. Subjects who plan to make significant changes to their lifestyle (e.g. diet, sleep, exercise) during the study period.
7. Subjects with smoking habits.
8. Subjects with high alcohol consumption (60g or more of pure alcohol per day).
9. Subjects with irregular lifestyles due to night shifts.
10. Female subjects who are pregnant or lactating, or intending to become pregnant during the study.
11. Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study.
12. Subjects deemed unsuitable by the investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Arikawa |
Organization
Bi-ba Coporation
Division name
Representative Director
Zip code
753-0086
Address
1-20,Nakaichi-cho,Yamaguchi City
TEL
090-3869-7550
bi.ba.sports.school@gmail.com
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Nakatani |
Organization
Yamaguchi Healthlab
Division name
General Manager
Zip code
754-0041
Address
Medifitlab 3F,1-1-2, Ogori-reiwa,Yamaguchi City
TEL
083-976-4095
Homepage URL
info@yamaguchi-hl.com
Sponsor or person
Institute
Bi-ba Coporation
Institute
Department
Personal name
Funding Source
Organization
Bi-ba Coporation
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | 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 | 28 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 25 | 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 | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071846
