UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061024 |
|---|---|
| Receipt number | R000069836 |
| Scientific Title | An interventional study on the effects of communication modality (face-to-face vs. online) and interpersonal relationship on autonomic nervous activity and postprandial glucose response |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 19:15:42 |
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Basic information
Public title
Effects of social interaction (face-to-face and online) and interpersonal relationships on postprandial blood glucose levels
Acronym
Effects of social interaction (face-to-face and online) and interpersonal relationships on postprandial blood glucose levels
Scientific Title
An interventional study on the effects of communication modality (face-to-face vs. online) and interpersonal relationship on autonomic nervous activity and postprandial glucose response
Scientific Title:Acronym
An interventional study on the effects of communication modality (face-to-face vs. online) and interpersonal relationship on autonomic nervous activity and postprandial glucose response
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how communication modality (face-to-face vs. online) and interpersonal relationship (friends vs. strangers) affect autonomic nervous activity and postprandial blood glucose levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial glucose levels measured by continuous glucose monitoring
Key secondary outcomes
Heart rate variability (autonomic nervous activity)
Blood pressure
Salivary cortisol
Subjective measures (emotion, stress, sleepiness)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants undergo a 75 g oral glucose tolerance test, followed by a 30-minute conversation session.Four experimental conditions are conducted within the same participants
FriendFace to face
FriendOnline
StrangerFace to face
StrangerOnline
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged from 18 to 30 years who provide informed consent
Key exclusion criteria
Individuals with diabetes or metabolic disorders
Individuals with infection symptoms
Individuals with sleep deprivation
Individuals using implanted medical devices
Individuals with alcohol allergy or skin conditions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Faculty of Science and Engineering
Zip code
5258577
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
TEL
0775614939
s-okada@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | shima |
| Middle name | |
| Last name | okada |
Organization
Ritsumeikan University
Division name
Faculty of Science and Engineering
Zip code
5258577
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
TEL
0775614939
Homepage URL
s-okada@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Research Ethics Committee, Ritsumeikan University
Address
1-1-1, Nojihigashi,Kusatsu,Shiga,Japan
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 | 23 | 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
24
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
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | 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 | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069836
