UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023775 |
|---|---|
| Receipt number | 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 | 2020/12/04 14:44:21 |
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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 | Teruhiko |
| Middle name | |
| Last name | Koike |
Organization
Nagoya University
Division name
Graduate School of Medicine/Research center of health, physical fitness and sports
Zip code
464-8601
Address
Furo-cho, Chikusaku, Naoya
TEL
052-789-3963
koike@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Ogawa |
Organization
Nagoya University
Division name
Graduate school of education and human development
Zip code
464-8601
Address
Furo-cho, Chikusaku, Nagoya
TEL
052-789-5927
Homepage URL
ogawa-ma@nagoya-u.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
Nagoya University
Address
Furo-cho, Chikusaku, Nagoya
Tel
052-789-5927
ogawa-ma@nagoya-u.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
| 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027369
| Research Plan | |
|---|---|
| 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 |
