UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057556 |
|---|---|
| Receipt number | R000065763 |
| Scientific Title | Investigation of the relationship between physical activity, body composition, physical function, intestinal environment, and biological indices in the Japanese population |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 18:41:44 |
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Basic information
Public title
Investigation of the relationship between physical activity, body composition, physical function, intestinal environment, and biological indices in the Japanese population
Acronym
the relationship between physical activity, body composition, physical function, intestinal environment, and biological indices in the Japanese population
Scientific Title
Investigation of the relationship between physical activity, body composition, physical function, intestinal environment, and biological indices in the Japanese population
Scientific Title:Acronym
the relationship between physical activity, body composition, physical function, intestinal environment, and biological indices in the Japanese population
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between physical activity, body composition and physical function, and intestinal environment, eating habits and frailty in healthy adults aged 18 years and older living in the community, and to clarify the correlation between these variables.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the correlation between measured variables
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Single dose of sodium bromide. 10-20 mg/kg per body weight.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants must be men and women who are willing to participate in this study and must be at least 18 years of age. There is no upper age limit.
Key exclusion criteria
Persons diagnosed with dementia and unable to obtain their consent
Persons who are unable to collect urine alone
Persons who are unable to collect samples (double-labeled water and sodium bromide) properly
Persons who are in poor physical condition such as fever
Persons who are unable to record the number of steps taken during the measurement period
Persons who cannot remember what they usually eat
Persons who are wearing a cardiac pacemaker
The following are excluded from the study because sodium bromide administration is contraindicated
Persons with a history of hypersensitivity to sodium bromide or bromine compounds.
Persons with renal dysfunction.
Persons with dehydration or general weakness.
Persons with organic brain damage or depression
Persons with glaucoma
Persons consuming a low-sodium diet
Translated with www.DeepL.com/Translator (free version)
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Center for Physical Activity Research
Zip code
566-0002
Address
Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan
TEL
(+81)6-6384-1120
yyamada831@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Center for Physical Activity Research
Zip code
566-0002
Address
Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan
TEL
(+81)6-6384-1120
Homepage URL
yyamada831@gmail.com
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Internal funding
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
Institutional Review Board, National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan
Tel
072-641-9811
irb-office@nibn.go.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
| 2025 | Year | 04 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065763
