UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024457 |
|---|---|
| Receipt number | R000026320 |
| Scientific Title | The influence of lifestyle on balance of nitric oxide among healthy Japanese |
| Date of disclosure of the study information | 2016/10/18 |
| Last modified on | 2016/10/18 12:40:36 |
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Basic information
Public title
The influence of lifestyle on balance of nitric oxide among healthy Japanese
Acronym
The influence of lifestyle on balance of nitric oxide among healthy Japanese
Scientific Title
The influence of lifestyle on balance of nitric oxide among healthy Japanese
Scientific Title:Acronym
The influence of lifestyle on balance of nitric oxide among healthy Japanese
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Movement was studied focused on vascular endothelial cell function and closely related to nitric oxide (NO) in order to consider a good impact on the lifestyle-related diseases such as blood pressure and hardening of the arteries.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Pressure
Key secondary outcomes
Systolic Blood Pressure
Diastilic Blood Pressure
Serum Citrulline
Serum Arginine
Serum Ornithine
Serum Urea
Serum NO2
Serum Nox
Serum Arginase
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The bicycle exercise using the exercise equipment, 5 days a week, one hour each day, the implementation of four weeks (a total of 20 hours).
Movement of moderate exercise intensity is that a guideline of 60% of the maximum oxygen uptake
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
Healthy subjecys
Subjects who sign an infomed consent form to participate in the study
People there is no exercise habits
Key exclusion criteria
People who are taking medicine to lower the blood pressure cholesterol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiki Ogino |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Public Health
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama,Japan
TEL
086-235-7184
public@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiki Ogino |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Public Health
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama,Japan
TEL
086-235-7184
Homepage URL
public@md.okayama-u.ac.jp
Sponsor or person
Institute
None
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 18 | 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
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
| 2013 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2016 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026320
