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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023775
Receipt No. R000027369
Scientific Title Effects of nutrition and physical activity on ectopic fat in the human skeletal muscle
Date of disclosure of the study information 2016/10/01
Last modified on 2017/03/31

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Basic information
Public title Effects of nutrition and physical activity on ectopic fat in the human skeletal muscle
Acronym Effects of nutrition and physical activity on ectopic fat in the human skeletal muscle
Scientific Title Effects of nutrition and physical activity on ectopic fat in the human skeletal muscle
Scientific Title:Acronym Effects of nutrition and physical activity on ectopic fat in the human skeletal muscle
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the relation of the nutrition situation and daily physical activity level on the ectopic fat into the lower limbs and trunk muscle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Magnetic resonance image
Key secondary outcomes Body composition
Ultrasonographic image
Physical function
Blood test
Physical activity level
Questions about the physical condition
Nutrition condition

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Measurement of physical activity level for 14 days
Interventions/Control_2 Nutrition survey
Interventions/Control_3 Magnetic resonance image
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria BMI is under 25
Without the need for assistance
Capable of self-walking
Key exclusion criteria Subjects who has artifacts, such as a metal object into the body,cardiac pacemaker, heart valve prosthesis, brain aneurysm metal clip,artificial joint, cochlear implant, magnetic removable dentures and so on.
Need of assistance daily life.
Subject who has
-tattoos and arts makeup
-claustrophobia
Subjects who has felt unconfortable during MR and ultrasound eximination.
Subjects who is prohibit execise by doctor.
Subjects who is impassible to walk alone for 5 min.
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Oshida
Organization Nagoya University
Division name Graduate School of Medicine/Research center of health, physical fitness and sports
Zip code
Address Furo-cho, Chikusaku, Naoya
TEL 052-789-3961
Email oshida@htc.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Madoka Ogawa
Organization Nagoya University
Division name Graduate school of education and human development
Zip code
Address Furo-cho, Chikusaku, Nagoya
TEL 052-789-5927
Homepage URL
Email ogawa-ma@nagoya-u.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Government offices of other countries
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 01 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
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 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 08 Month 26 Day
Last modified on
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027369

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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