UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032913 |
|---|---|
| Receipt number | R000037528 |
| Scientific Title | The effects of different physical activity levels during a single day on energy intake, appetite, and energy balance |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2019/04/01 17:59:41 |
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Basic information
Public title
The effects of different physical activity levels during a single day on energy intake, appetite, and energy balance
Acronym
Effects of physical activity on energy balance
Scientific Title
The effects of different physical activity levels during a single day on energy intake, appetite, and energy balance
Scientific Title:Acronym
Effects of physical activity on energy balance
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 the diffirence of physical activity levels on energy intake, energy balance and blood glucose.
Basic objectives2
Others
Basic objectives -Others
Relatoinship between physical activity volume and continuous blood glucose.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy intake, energy balance and continuous blood glucose during interventions.
Key secondary outcomes
Rating of appetite and feeling
Respiration quotient
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sedentary activity during a day.
Interventions/Control_2
7 times of 25 minutes walking during a day.
Interventions/Control_3
7 times of 25 minutes running during a day.
Interventions/Control_4
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Living a regular wake/sleep and without regular exercise
Key exclusion criteria
Smoker, diabetes
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hatamoto |
| Middle name | |
| Last name | Yoichi |
Organization
Fukuoka University
Division name
Fukuoka University Institute for Physical Activity
Zip code
814-0180
Address
19-1, Nanakuma 8-Chome, Jonan-ku, Fukuoka
TEL
092-871-6631
y.hatamoto.7@gmail.com
Public contact
Name of contact person
| 1st name | Hatamoto |
| Middle name | |
| Last name | Yoichi |
Organization
Fukuoka University
Division name
Fukuoka University Institute for Physical Activity
Zip code
814-0180
Address
19-1, Nanakuma 8-Chome, Jonan-ku, Fukuoka
TEL
092-871-6631
Homepage URL
y.hatamoto.7@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Institute for Physical Activity via the Central Research Institute of Fukuoka University (no. 136009) and the Kao Research Council for the study of Healthcare Science (B-52004).
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Fukuoka University
Address
8-19-1 Nanakuma, Jonan-ku,Fukuoka, Japan
Tel
092-871-6631
pj.ca.u-akoukuf.mda@nisius
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 | 06 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/11/3/690
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/11/3/690
Number of participants that the trial has enrolled
9
Results
The present study has shown that PA levels equivalent to RMR 1.26 and 2.13 during a single day do not influence
Results date posted
| 2019 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
young healthy men
Participant flow
Nine healthy male university students who did not undertake physical exercise more than once a week participated in the present study. The participants were recruited mainly via the laboratory information board at the Faculty of Sports and Health Science of Fukuoka University.
Adverse events
Nothing
Outcome measures
Enwrgy expenditure
Energy intake
Appetite
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037528
| 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 |
