UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061046 |
|---|---|
| Receipt number | R000069855 |
| Scientific Title | A Preliminary Study on the Effects of Dietary Management Using Digital Technology on Body Weight and Continuous Glucose Monitoring Parameters |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/24 23:53:19 |
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Basic information
Public title
A Preliminary Study on the Effects of Dietary Management Using Digital Technology on Body Weight and Continuous Glucose Monitoring Parameters
Acronym
Digital Dietary Management Pilot Study
Scientific Title
A Preliminary Study on the Effects of Dietary Management Using Digital Technology on Body Weight and Continuous Glucose Monitoring Parameters
Scientific Title:Acronym
Digital Dietary Management Pilot Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate changes in body weight and continuous glucose monitoring parameters associated with the use of digital dietary management tools voluntarily selected by the participants. Specifically, changes between Week 1 and Week 2 will be assessed in terms of absolute body weight change (kg) and relative body weight change (%), as well as changes in continuous glucose monitoring metrics, including mean glucose, coefficient of variation (CV), Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and Glucose Management Indicator (GMI).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Body Weight Change
2) Continuous Glucose Monitoring Parameters
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During Week 1, participants will undergo an observation period without the use of digital dietary management tools. During Week 2, they will engage in a dietary management period using a generative AI tool, a diet and health management application, or both, according to their own choice. Throughout the study period, continuous glucose monitoring using the FreeStyle Libre 2, daily body weight measurement, and meal photo recording will be conducted. Prompts entered into the generative AI tool will not be standardized.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Adults aged 20 to 75 years
2) Able to perform basic smartphone or PC operations
3) Able to understand the study and provide written informed consent
4) Able to complete the 2-week observation period
5) Not meeting any exclusion criteria
Key exclusion criteria
1) Women who are pregnant or breastfeeding
2) Patients with diabetes receiving insulin therapy
3) Individuals who have undergone surgery requiring general anesthesia within the past 3 months
4) Individuals currently under treatment for severe psychiatric disorders
5) Individuals judged to have insufficient cognitive ability to understand the study and provide appropriate informed consent
6) Individuals for whom placement of the FreeStyle Libre 2 sensor is difficult (e.g., severe skin disease, wounds or infection at the application site, history of adhesive allergy, or physical difficulty in sensor placement)
7) Individuals currently receiving treatment for eating disorders
8) Individuals on dialysis or with urinary protein of 1+ or greater
9) Individuals with severe hepatic dysfunction (Child-Pugh class C)
10) Individuals who have participated in another clinical study or trial within the past 1 month
11) Individuals judged by the principal investigator to be inappropriate for participation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoneda |
Organization
Kanazawa University
Division name
Department of Health Promotion and Medicine of the Future
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2778
mkome@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kometani |
Organization
Kanazawa University
Division name
Department of Health Promotion and Medicine of the Future
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2778
Homepage URL
mkome@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kanazawa University Ethics Committee
Address
Takara-machi 13-1, Kanazawa, Ishikawa
Tel
076-265-2000
rinri@adm.kanazawa-u.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 | 25 | 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 | 01 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 06 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069855
