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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Not targeting the disease. | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |