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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041361
Receipt No. R000047053
Scientific Title The effects of breaking up sedentary time with three different exercise intensities on energy expenditure, blood glucose and appetite.
Date of disclosure of the study information 2021/01/01
Last modified on 2020/08/09

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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

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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