UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032629
Receipt number 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 16:33:25

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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 or person

Institute

Graduate School of Integrated Arts and Sciences, Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.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