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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024457
Receipt No. 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

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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
Email 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
Email public@md.okayama-u.ac.jp

Sponsor
Institute None

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026320

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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