UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060912 |
|---|---|
| Receipt number | R000067078 |
| Scientific Title | Investigation of the effect of interaction with a chatbot on postprandial blood glucose levels |
| Date of disclosure of the study information | 2026/03/12 |
| Last modified on | 2026/03/12 16:10:15 |
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Basic information
Public title
Investigation of the effect of interaction with a chatbot on postprandial blood glucose levels
Acronym
Postprandial blood glucose investigation
Scientific Title
Investigation of the effect of interaction with a chatbot on postprandial blood glucose levels
Scientific Title:Acronym
Postprandial blood glucose investigation
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify whether the interaction with the chatbot can suppress the increase in postprandial blood glucose level and improve health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels at 0, 15, 30, 60, 90, and 120 minutes after ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Intervention 1: ingest glucose, talk to chatbot
Interventions/Control_2
Intervention 2: ingest glucose, talk to new person
Interventions/Control_3
Intervention 3: ingest glucose, rest, no conversation
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Twelve healthy male students of the University, aged between 18 and 30 years old
Key exclusion criteria
The following subjects should be excluded from the oral glucose tolerance test because of the risk of causing an exacerbation of metabolic abnormalities (worsening of symptoms such as thirst, frequent urination, and easy fatigue due to hyperglycemia) when the test is performed.
- Subjects with type 1 diabetes
- Subjects with type 2 diabetes
- Subjects with diabetic ketoacidosis
- Subjects with symptoms of fasting hyperglycemia
- Subjects with symptoms of infection
The following subjects are excluded because of the use of glucose monitoring system.
- Subjects who are using any kind of glucose monitoring device (because there is a possibility of incorrect measurement)
- Subjects who are using an implantable medical device such as a pacemaker (because there is a possibility of malfunction)
- Subjects who are allergic to alcohol or have sensitive skin (because alcohol disinfection is performed when the device is worn)
The following subjects are excluded from the study because of the possibility of affecting autonomic nervous system activity:
- Subjects who have not had enough sleep the night before the experiment
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Nishihara |
Organization
Ritsumeikan University
Division name
College of Information Science and Engineering
Zip code
5678570
Address
2-150, Iwakura, Ibaraki, Osaka
TEL
0726652858
nisihara@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Nishihara |
Organization
Ritsumeikan University
Division name
College of Information Science and Engineering
Zip code
5678570
Address
2-150, Iwakura, Ibaraki, Osaka
TEL
0726652858
Homepage URL
nisihara@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Ritsumeikan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University
Address
1-1-1, Nojihigashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.ac.jp
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 | 03 | Month | 12 | 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
12
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
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067078
