UMIN-CTR Clinical Trial

Basic information
Public title	Impact exercise and diet load on the blood flow of the celiac artery and superior mesenteric artery
Acronym	Impact exercise and diet load on the blood flow of the celiac artery and superior mesenteric artery
Scientific Title	Impact exercise and diet load on the blood flow of the celiac artery and superior mesenteric artery
Scientific Title:Acronym	Impact exercise and diet load on the blood flow of the celiac artery and superior mesenteric artery
Region	Japan

Condition
Condition	volunteer(healthy)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	examine the influence of exercise and diet load on the blood flow of the celiac artery and superior mesenteric artery
Basic objectives2	Others
Basic objectives -Others	measure changes in blood flow by ultrasonograph
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood flow of the celiac artery and superior mesenteric artery
Key secondary outcomes

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	Educational,Counseling,Training
Type of intervention	Food Other
Interventions/Control_1	exercise:play with the treadmill 10 min. diet load:Calorie Mate and tea
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A healthy person
Key exclusion criteria	Heart disease
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoko Takenouchi
Organization	Kawasaki Medical School Hospital
Division name	Ccentral inspection department
Zip code
Address	577 Matsushima, Kurashiki-city,Okayama
TEL	086-462-1111
Email	proton@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoko Takenouchi
Organization	Kawasaki Medical School Hospital
Division name	Ccentral inspection department
Zip code
Address	577 Matsushima, Kurashiki-city,Okayama
TEL	086-462-1111
Homepage URL
Email	proton@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School Hospital
Institute
Department

Funding Source
Organization	Kawasaki Medical School Hospital
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
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	2017 Year 07 Month 21 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	2016 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 19 Day
Last follow-up date	2016 Year 11 Month 15 Day
Date of closure to data entry	2016 Year 11 Month 20 Day
Date trial data considered complete	2016 Year 11 Month 27 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 07 Month 21 Day
Last modified on	2017 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025500

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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