UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062316 |
|---|---|
| Receipt number | R000071314 |
| Scientific Title | Evaluation of Postprandial Autonomic, Hemodynamic, and Glucose Responses Using Smart Ring-Derived Photoplethysmographic Indices: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/23 15:07:49 |
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Basic information
Public title
Study of Postprandial Physiological State Assessment Using a Smart Ring
Acronym
Smart Ring Postprandial Response Study (SRPR Study)
Scientific Title
Evaluation of Postprandial Autonomic, Hemodynamic, and Glucose Responses Using Smart Ring-Derived Photoplethysmographic Indices: A Randomized Crossover Trial
Scientific Title:Acronym
Evaluation of Postprandial Autonomic, Hemodynamic, and Glucose Responses Using Smart Ring-Derived Photoplethysmographic Indices: SRPR Study
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantify autonomic nervous system responses to a postprandial challenge using photoplethysmography (PPG)-derived indices obtained from a wearable device and to evaluate their validity. Heart rate variability indices will be used as the primary outcome measures to assess changes from the preprandial resting state to the postprandial period. In addition, postprandial hemodynamic responses, including changes in blood pressure, and metabolic responses will be assessed as reference measures for the integrated interpretation of physiological responses. For this purpose, glucose measurements obtained by self-monitoring of capillary blood glucose and glucose dynamics measured by continuous glucose monitoring (CGM) will be collected to the minimum extent necessary, and their associations with wearable device-derived indices will be examined as secondary outcomes. The findings will clarify the extent to which information obtained from a smart ring reflects changes in physiological state and will contribute to the research and development of physiological state assessment technologies using wearable devices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response of heart rate variability to the acute diet
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
180 g jelly beverage containing 45 g of carbohydrate
Interventions/Control_2
180 g jelly beverage containing 22.5 g of carbohydrate
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 to <65 years
Provision of written informed consent
Ability and willingness to perform self-monitoring of capillary blood glucose by finger-stick sampling
Key exclusion criteria
Hypertension
Diabetes mellitus
Cardiovascular disease
Neurological disease
Pregnancy
Current use of medications that may affect cardiovascular function
Gastrointestinal disease
History of gastrointestinal surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Sugawara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Integrated Research Center for Self-Care Technology
Zip code
3058566
Address
1-1-1 Higashi, Tsukbua, Ibaraki, Japan
TEL
080-2203-6943
jun.sugawara@aist.go.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Sugawara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Integrated Research Center for Self-Care Technology
Zip code
3058566
Address
1-1-1 Higashi, Tsukbua, Ibaraki, Japan
TEL
080-2203-6943
Homepage URL
jun.sugawara@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, National Institute of Advanced Industrial Science and Technology (AIST)
Address
1-1-1 Higashi, Tsukuba, Ibaraki, Japan
Tel
029-861-2120
safe-life-ml@aist.go.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 | 08 | 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
| 2026 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | 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 | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071314
