UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exercise before breakfast increases 24-h fat oxidation in male and female subjects
Title of the study (Brief title)	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	IWAYAMA Kaito
Organization	University of Tsukuba.
Division name	Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences.
Address	Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	090-5223-4083
Email	kaito.iwayama@jpnsport.go.jp

Public contact
Name of contact person	IWAYAMA Kaito
Organization	University of Tsukuba.
Division name	Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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