UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037597 |
|---|---|
| Receipt number | R000042299 |
| Scientific Title | A relationship between running and changes of blood ketone body |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2022/02/08 10:28:45 |
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Basic information
Public title
A relationship between running and changes of blood ketone body
Acronym
Running and blood ketone body
Scientific Title
A relationship between running and changes of blood ketone body
Scientific Title:Acronym
Running and blood ketone body
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating a relationship between exercise intensity/duration and body fat combustion with observing the changes of blood ketone body concentration during running
Basic objectives2
Others
Basic objectives -Others
Assisting in prolonging healthy life expectancy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A comparison of the changes of blood ketone body concentration with running depends on exercise intensity or duration
Key secondary outcomes
A comparison of the changes of blood glucose concentration with running depends on exercise intensity
A comparison of the changes of blood glucose concentration with running depends on exercise duration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Treadmill running for 30 or 60 min
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The students of Tokyo University of Science "who belongs to the official sports club of the university and takes exercise in the club twice a week or more" or "who runs 50 km a month or longer"
Key exclusion criteria
Those with a medical history of cardiovascular diseases, hypertension, diabetes or severe respiratory diseases
Patients of orthopedic diseases who cannot make treadmill running
Those with taking medications including OTCs
Pregnant women
Those who belongs to the laboratory of the principal investigator of this research
Those who are judged to be unsuited for this trial by the principal investigator of this research
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo University of Science
Division name
Department of Pharmacy, Faculty of pharmaceutical sciences
Zip code
278-8510
Address
2641 Yamazaki, Noda, Chiba 278-8510, Japan
TEL
04-7124-1501
tatsunori.s@rs.tus.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo University of Science
Division name
Department of Pharmacy, Faculty of pharmaceutical sciences
Zip code
278-8510
Address
2641 Yamazaki, Noda, Chiba 278-8510, Japan
TEL
04-7124-1501
Homepage URL
tatsunori.s@rs.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo University 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
The Ethical Review Committee at Tokyo University of Science
Address
2641 Yamazaki, Noda, Chiba 278-8510, Japan
Tel
04-7124-1501
bio@admin.tus.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 | 08 | Month | 05 | 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
12
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
| 2019 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042299
| Research Plan | |
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| 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 |
