UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043749 |
|---|---|
| Receipt number | R000049913 |
| Scientific Title | Creation of a health management system focusing on the time axis (research focusing on postprandial blood glucose fluctuation) |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2022/05/10 06:46:42 |
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Basic information
Public title
Creation of a health management system focusing on the time axis (research focusing on postprandial blood glucose fluctuation)
Acronym
Creation of a health management system focusing on the time axis (research focusing on postprandial blood glucose fluctuation)
Scientific Title
Creation of a health management system focusing on the time axis (research focusing on postprandial blood glucose fluctuation)
Scientific Title:Acronym
Creation of a health management system focusing on the time axis (research focusing on postprandial blood glucose fluctuation)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clarify the factors of individual differences in blood glucose fluctuation by monitoring many biological information over time.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify how differences in lifestyle affect various changes in biometric information at the group or individual level.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose fluctuation and postprandial glucose level
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
Self control
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
Day1-2, breakfast skipping and late dinner
Day3-5, breakfast eating and early dinner
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects are adult men and women aged 20 years or older who have obtained the consent of this study. Those who are 20 years of age or older and who have sufficient judgment ability and can obtain consent from the person who do not meet the exclusion criteria are targeted.
Key exclusion criteria
1. Person under 20 years old
2. Persons who have regular drugs (drugs that affect metabolism such as diabetes treatment, alpha-blockers, beta-blockers, etc.)
3. Persons with diseases that affect metabolism (diabetes, thyroid function)
4. Persons with a diagnosis of mental illness and those with a medical history
5. Persons using implantable medical devices such as pacemakers
6. Persons with serious cardiovascular disease
7. Persons with acute cancer
8. Persons with a history of gastrointestinal surgery (mainly applicable to esophagus, stomach, duodenum, small intestine, colon, and liver.
9. Persons with knee or lower back illness that interfere with work, pregnant women
10. People with extremely irregular eating habits
11. Persons with exercise habits (average 60 minutes / day or more)
12. Persons who are participating in or willing to participate in tests for ingesting other foods or taking drugs, and tests for applying cosmetics and drugs.
13. Persons who do not have a photography function on their mobile phones
14. Persons who cannot install the app
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Yoshimura |
Organization
National Institute Health and Nutrition
Division name
Department of Nutritional Science
Zip code
1628636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332035721
eyoshi@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Moritake |
Organization
National Institute Health and Nutrition
Division name
Strategic Planning Department
Zip code
1628636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332035721
Homepage URL
eiken-chousei@nibiohn.go.jp
Sponsor or person
Institute
National Institute Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito Asagi, Ibaraki-shi, Osaka
Tel
0726419829
irb-office@nibiohn.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
| 2022 | Year | 05 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2021 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049913
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
