UMIN-CTR Clinical Trial

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
Email	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
Email	eiken-chousei@nibiohn.go.jp

Sponsor
Institute	National Institute Health and Nutrition
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049913

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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