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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040638
Receipt No. R000046380
Scientific Title Effects of exercise before breakfast on 24 h fat oxidation and plasma fatty acid profile
Date of disclosure of the study information 2020/06/03
Last modified on 2020/06/03

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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

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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