UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040638 |
|---|---|
| Receipt number | 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 14:44:11 |
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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
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
k-iwayama@sta.tenri-u.ac.jp
Sponsor or person
Institute
Doctoral Program in Sports Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046380
