UMIN-CTR Clinical Trial

Basic information
Public title	The effects of breaking up sedentary time with three different exercise intensities on energy expenditure, blood glucose and appetite.
Acronym	The effects of breaking up sedentary time with three different exercise intensities on the energy metabolism.
Scientific Title	The effects of breaking up sedentary time with three different exercise intensities on energy expenditure, blood glucose and appetite.
Scientific Title:Acronym	The effects of breaking up sedentary time with three different exercise intensities on the energy metabolism.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of breaking up sedentary time with three different exercise intensities on the energy metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Energy expenditure
Key secondary outcomes	Glucose concentration Visual analog scale (Appetite) Physical activity Appetite

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	6
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	1. Breaking up sedentary time with vigorous intensity of running 2. Breaking up sedentary time with moderate intensity of running 3. Breaking up sedentary time with mild intensity of running Total times were 16 times per day every 30 minutes. One day is performed per condition.
Interventions/Control_2	The order of condition is (1,3,2).
Interventions/Control_3	The order of condition is (2,3,1).
Interventions/Control_4	The order of condition is (2,1,3).
Interventions/Control_5	The order of condition is (3,1,2).
Interventions/Control_6	The order of condition is (3,2,1).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	1.Subjects who can make self-judgment and are voluntarily giving written informed consent. 2. BMI range: 25.0-40.0 kg/m2 3. Over-weight and obesity but healthy subjects 4. Who is approved participation by the doctor
Key exclusion criteria	1.Do not meet the above criteria 2.Who are not prohibited from exercising by a doctor. 3.Subjects who have diabetes 4.Subjects who have past surgical history of gastroenterological surgery. 5.Past medical history of kidney disease. 6.Subjects who use pharmaceuticals regularly. 7.Subjects who excessive alcohol intake and who have a smoking habit. 8.Subjects who is irregular eating habits. 9.Subjects who are participating or will participate other clinical trials. 10.Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name YOICHI Middle name Last name HATAMOTO
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81-92-871-6631
Email	yhatamoto@nibiohn.go.jp

Public contact
Name of contact person	1st name YOICHI Middle name Last name HATAMOTO
Organization	same as above
Division name	same as above
Zip code	8140180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	+81928716631
Homepage URL
Email	yhatamoto@nibiohn.go.jp

Sponsor
Institute	Fukuoka university
Institute
Department

Funding Source
Organization	None
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	same as above
Address	same as above
Tel	0928716631
Email	yhatamoto@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	2021 Year 01 Month 01 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	2017 Year 04 Month 07 Day
Date of IRB	2017 Year 04 Month 07 Day
Anticipated trial start date	2017 Year 04 Month 07 Day
Last follow-up date	2020 Year 04 Month 01 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 08 Month 09 Day
Last modified on	2020 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047053