UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041361 |
|---|---|
| Receipt number | 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 00:04:26 |
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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
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
yhatamoto@nibiohn.go.jp
Sponsor or person
Institute
Fukuoka university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047053
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
