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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032629
Receipt No. R000037202
Scientific Title Influence of the timing of meals and exercise for glucose control using continuous glucose monitoring system
Date of disclosure of the study information 2018/05/17
Last modified on 2018/05/17

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Basic information
Public title Influence of the timing of meals and exercise for glucose control using continuous glucose monitoring system
Acronym Influence of the timing of meals and exercise for glucose control
Scientific Title Influence of the timing of meals and exercise for glucose control using continuous glucose monitoring system
Scientific Title:Acronym 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
1st name
Middle name
Last name Kentaro Kawanaka
Organization Fukuoka University
Division name Faculty of Sports and Health Science
Zip code
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
1st name
Middle name
Last name Kentaro Kawanaka
Organization Fukuoka University
Division name Faculty of Sports and Health Science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2018 Year 01 Month 26 Day
Date of IRB
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

Other
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

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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