UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of the timing of meals and exercise for glucose control using continuous glucose monitoring system
Title of the study (Brief title)	Influence of the timing of meals and exercise for glucose control
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of meal and exercise timing on blood glucose and hormone
Basic objectives2	Others
Basic objectives -Others	Exercise nutrition
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Continuous blood glucose at meal and exercise interventions Hormone and blood parameter (glucose, insulin, C-peptide, triglyceride, free fatty acid, and glucagon)
Key secondary outcomes	Body temperature Rating of appetite and feeling

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	meal intervention (3 meals)
Interventions/Control_2	meal intervention (breakfast skipping)
Interventions/Control_3	Postprandial exercise 30-min after meal for 30-min, intensity at lactate threshold
Interventions/Control_4	Brief periodic exercise 25-min, 55-min, 85-min, 115-min, 145-min, 175-min, 205-min, 235-min and 265-min after meal, 3 sets of 1-min exercise (jogging) and a 30-s rest, intensity at lactate threshold
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	30 years-old >
Gender	Male
Key inclusion criteria	Living a regular wake/sleep and without regular exercise
Key exclusion criteria	Smoker, diabetes
Target sample size	8

Research contact person
Name of lead principal investigator	Kentaro Kawanaka
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	19-1, Nanakuma 8-Chome, Jonan-ku, Fukuoka
TEL	092-871-6631
Email	kawanaka@fukuoka-u.ac.jp

Public contact
Name of contact person	Kentaro Kawanaka
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Address	19-1, Nanakuma 8-Chome, Jonan-ku, Fukuoka
TEL	092-871-6631
Homepage URL
Email	kawanaka@fukuoka-u.ac.jp

Sponsor
Institute	Graduate School of Integrated Arts and Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 26 Day
Anticipated trial start date	2018 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 17 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037202