UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038252 |
|---|---|
| Receipt number | R000043606 |
| Scientific Title | Effect of a single bout of exercise on clock genes expression in human leukocyte |
| Date of disclosure of the study information | 2019/10/10 |
| Last modified on | 2020/09/23 17:51:00 |
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Basic information
Public title
Effect of a single bout of exercise on clock genes expression in human leukocyte
Acronym
Effect of exercise on clock genes expression in leukocyte
Scientific Title
Effect of a single bout of exercise on clock genes expression in human leukocyte
Scientific Title:Acronym
Effect of exercise on clock genes expression in leukocyte
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether exercise affects level and phase of clock genes expression in human leukocytes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clock gene expression (Bmal1, Clock, Per1-3, Cry1-2) in human leukocyte in the day of exercise session
Key secondary outcomes
Core body temperature in the day of exercise session
energy metabolism
insulin concentration
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
[Morning exercise trial]
Perform a 60% VO2max bicycle ergometer exercise from 7:00 to 8:00
Interventions/Control_2
[Afternoon exercise trial]
Perform a 60% VO2max bicycle ergometer exercise from 16:00 to 17:00
Interventions/Control_3
[Control trial]
No exercise
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Subjects were recreationally active but untrained individuals, who perform moderate exercise 2-4 days/week.
Subjects had no current medical conditions, none were taking any medications at the time of study and were non-smokers.
Subjects wrote informed consent.
Key exclusion criteria
People who have habitually intense training.
People who taking some medications.
People who do not agree.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tokuyama |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8550
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
tokuyama.kumpei.gf@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Tanaka |
Organization
University of Tsukuba
Division name
Sports Medicine
Zip code
305-8550
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
09015357079
Homepage URL
yoshi.tanaka.5212@gmail.com
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty Health and Sport Sciences, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
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
| 2019 | Year | 10 | Month | 10 | 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
11
Results
Results date posted
Results Delayed
Results Delay Reason
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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043606
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
