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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025325
Receipt No. 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

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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
Email 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
Email kaito.iwayama@jpnsport.go.jp

Sponsor
Institute University of Tsukuba.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029130

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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