UMIN-CTR Clinical Trial

Basic information
Public title	Effects of exercise before breakfast on 24 h fat oxidation and plasma fatty acid profile
Acronym	Effects of exercise before breakfast on 24 h fat oxidation and plasma fatty acid profile
Scientific Title	Effects of exercise before breakfast on 24 h fat oxidation and plasma fatty acid profile
Scientific Title:Acronym	Effects of exercise before breakfast on 24 h fat oxidation and plasma fatty acid profile
Region	Japan

Condition
Condition	Not targeting the disease.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study was to clarify whether effect of exercise on concentration and composition of plasma FFA, which may underlie distinct effect of exercise on 24 h fat oxidation, depends on a nutritional state when exercise is performed.
Basic objectives2	Others
Basic objectives -Others	The second aim of the study was to clarify whether the transient decrease in glycogen store after exercise is related to increase in plasma FFA concentration.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood samples were taken into test tubes coated with EDTA at 6:30, 8:30, 15:30, 17:30 and 6:30 of next day. Total fatty acids, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids were measured.
Key secondary outcomes	Glucose, insulin, beta-hydroxybutyrate.

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	Subjects enterd the metabolic chamber for 24 h, and performed experimental exercise for 60 min before breakfast. Subjects slept for 7 h from 23:00 to 6:00.
Interventions/Control_2	Subjects enterd the metabolic chamber for 24 h, and performed experimental exercise for 60 min after lunch. Subjects slept for 7 h from 23:00 to 6:00.
Interventions/Control_3	Subjects enterd the metabolic chamber for 24 h, and kept sedentary condition. Subjects slept for 7 h from 23:00 to 6:00.
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	21 years-old <=
Age-upper limit	33 years-old >=
Gender	Male
Key inclusion criteria	Healthy acitive men.
Key exclusion criteria	All subjects had no current medical conditions, were not taking any medications at the time of the study, and were non-smokers.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kaito Middle name Last name IWAYAMA
Organization	Tenri University.
Division name	Faculty of Budo and Sport Studies
Zip code	632-0071
Address	80 Tainoshocho, Tenri, Nara.
TEL	0743-61-5348
Email	k-iwayama@sta.tenri-u.ac.jp

Public contact
Name of contact person	1st name Kaito Middle name Last name IWAYAMA
Organization	Tenri University
Division name	Faculty of Budo and Sport Studies
Zip code	632-0071
Address	80 Tainoshocho, Tenri, Nara.
TEL	0743-61-5348
Homepage URL
Email	k-iwayama@sta.tenri-u.ac.jp

Sponsor
Institute	Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba.
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of the University of Tsukuba
Address	1-1-1, Tennodai, Tsukuba-shi, Ibaraki.
Tel	029-853-2571
Email	hitorinri@un.tsukuba.ac.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	2020 Year 06 Month 03 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	10
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Not ready to submit in an academic journal.
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 07 Month 10 Day
Date of IRB	2014 Year 09 Month 16 Day
Anticipated trial start date	2015 Year 03 Month 05 Day
Last follow-up date	2015 Year 11 Month 27 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 06 Month 03 Day
Last modified on	2020 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046380