UMIN-CTR Clinical Trial

Basic information
Public title	Study of meal timing on postprandial interstitial fluid glucose levels
Acronym	Study of meal timing on postprandial interstitial fluid glucose levels
Scientific Title	Study of meal timing on postprandial interstitial fluid glucose levels
Scientific Title:Acronym	Study of meal timing on postprandial interstitial fluid glucose levels
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the impact of meal timing on postprandial interstitial fluid glucose levels
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interstitial fluid glucose levels
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	Prevention
Type of intervention	Food
Interventions/Control_1	The same meal three times a day consecutively, thereby satisfying their daily energy requirements
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Individuals whose BMI is between 18.5-25. 2) Individuals who are not have life style related diseases. 3) Individuals who avoid excessive exercise. during the intervention period. 4) Individuals who aged 20-65.
Key exclusion criteria	1) Individuals who have week skin and get a skin rash after bandage. 2) Individuals who are or are possibly pregnant, or are lactating. 3) Individuals who use an implantable medical devices such as pacemakers. 4)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 20g/day). 5)Individuals who are a smoker.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Yoshida
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	4228526
Address	52-1Yada Suruga-ku Shizuoka 422-8526, Japan
TEL	0542645561
Email	t-yoshida@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Yoshida
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	4228526
Address	52-1Yada Suruga-ku Shizuoka 422-8526, Japan
TEL	0542645561
Homepage URL
Email	t-yoshida@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	University of Shizuoka
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	University of Shizuoka
Address	52-1Yada Suruga-ku, Shizuoka, Japan
Tel	0542645561
Email	rinri@u-shizuoka-ken.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	2020 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	9
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	2020 Year 03 Month 16 Day
Date of IRB	2020 Year 03 Month 16 Day
Anticipated trial start date	2020 Year 03 Month 16 Day
Last follow-up date	2020 Year 08 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	2020 Year 03 Month 25 Day
Last modified on	2020 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045537