UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025325 |
|---|---|
| Receipt number | R000029130 |
| Scientific Title | Exercise before breakfast increases 24-h fat oxidation in male and female subjects |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2016/12/19 16:03:47 |
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Basic information
Public title
Exercise before breakfast increases 24-h fat oxidation in male and female subjects
Acronym
Exercise before breakfast increases 24-h fat oxidation in male and female subjects
Scientific Title
Exercise before breakfast increases 24-h fat oxidation in male and female subjects
Scientific Title:Acronym
Exercise before breakfast increases 24-h fat oxidation in male and female subjects
Region
| Japan |
Condition
Condition
Young healthy male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether there are sex-based differences in response of 24 h fat oxidation to exercise performed in post-absorptive state.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fat oxidation during 24-h.
Key secondary outcomes
Relative energy and nutrient balance, respiratory 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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
24-h calorimetry trials with exercise sessions perform before breakfast.
Interventions/Control_2
24-h calorimetry trials without exercise sessions perform before breakfast.
Interventions/Control_3
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are physically moderate active but none of them engaged the endurance training.
Key exclusion criteria
All subjects have no current medical conditions, and none are taking any medications including oral contraceptives at the time of the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | IWAYAMA Kaito |
Organization
University of Tsukuba.
Division name
Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences.
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
090-5223-4083
kaito.iwayama@jpnsport.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | IWAYAMA Kaito |
Organization
University of Tsukuba.
Division name
Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences.
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
090-5223-4083
Homepage URL
kaito.iwayama@jpnsport.go.jp
Sponsor or person
Institute
University of Tsukuba.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Address
Tel
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
| 2016 | Year | 12 | Month | 20 | 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
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Last modified on
| 2016 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029130
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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