UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052258 |
|---|---|
| Receipt number | R000059640 |
| Scientific Title | The relationship between skeletal muscles and lifestyle habits like nutrition and dietary habits |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2025/03/22 21:33:09 |
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Basic information
Public title
The relationship between skeletal muscles and lifestyle habits like nutrition and dietary habits
Acronym
The relationship between skeletal muscles and lifestyle habits like nutrition and dietary habits
Scientific Title
The relationship between skeletal muscles and lifestyle habits like nutrition and dietary habits
Scientific Title:Acronym
The relationship between skeletal muscles and lifestyle habits like nutrition and dietary habits
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate factors related with skeletal muscle mass and accmulation of intramuscular adipose tissue
Basic objectives2
Others
Basic objectives -Others
To evaluate factors related with skeletal muscle mass and accmulation of intramuscular adipose tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal muscle mass, intramuscular adipose tissue, nutrition and dietary habits, blood properties, physical performances, and physical activity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who have no difficulty in daily life and are not under treatment for cardiovascular, respiratory, or orthopedic diseases.
Males and females (who are not pregnant or possibly pregnant)
people who can understand the content of the research and have given written consent of their own free will.
people who are not claustrophobic, no metal or electronic devices in their bodies.
No tattoos or permanent eyeliner.
Key exclusion criteria
People who are unable to maintain their posture during MRI or ultrasound imaging.
People who have a conflict of interest with the principal investigator and research assistants (e.g., students taking classes)
People with dementia or mild cognitive impairment (cognitive TYM-J test score less than 42 points)
People with a diagnosis of a disease for which exercise is absolutely contraindicated.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Akima |
Organization
Nagoya University
Division name
Reseach Center of Health Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
052-789-3954
akima@nagoya-u.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | Ishiguro |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
052-789-3948
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nogoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the Research Center of Health, Physical Fitness and Sports
Address
Furo-cho, Chikusa-ku, Nagoya-shi, Aichi
Tel
052-789-3946
htc-rinri@adm.nagoya-u.ac.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
| 2023 | Year | 09 | Month | 20 | 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
50
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Height, body mass, body composition, skeletal muscle mass, IntraMAT, muscle thickness, echo intensity, nutrition and dietary habits, blood properties, physical functions, and daily physical activity
Management information
Registered date
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059640
