UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058576 |
|---|---|
| Receipt number | R000066908 |
| Scientific Title | Comparison of factors influencing body composition measurements by bioelectrical impedance analysis |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/24 10:50:11 |
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Basic information
Public title
Comparison of factors influencing body composition measurements by bioelectrical impedance analysis
Acronym
Comparison of factors influencing body composition measurements by bioelectrical impedance analysis
Scientific Title
Comparison of factors influencing body composition measurements by bioelectrical impedance analysis
Scientific Title:Acronym
Comparison of factors influencing body composition measurements by bioelectrical impedance analysis
Region
| Japan |
Condition
Condition
young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares how factors in daily life affect muscle mass and body water measurements obtained by bioelectrical impedance analysis
Basic objectives2
Others
Basic objectives -Others
This study aims to measure body composition under four conditions, such as exercise, diet, hydration, and posture, to compare their effects and help standardize the BIA measurement protocol.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass
Key secondary outcomes
body fat mass
total body water
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise: Perform 10 min of moderate-intensity aerobic exercise.
Interventions/Control_2
Diet: Consume a 200-kcal test meal.
Interventions/Control_3
Hydration: Ingest 500 mL of water.
Interventions/Control_4
Posture: Change posture from standing to supine.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 years or older and under 40 years, with no health problems.
2.Individuals who have received a full explanation of the study, sufficiently understood the contents, and voluntarily provided informed consent to participate.
Key exclusion criteria
1.Individuals with a history of allergies related to dairy products
2.Individuals with a pacemaker
3.Individuals currently undergoing treatment for any illness
4.Individuals who are currently pregnant
5.Individuals who, due to surgery or medication, may have altered fluid distribution and are deemed inappropriate as study participants by the principal investigator for ensuring the reliability of the research data
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
as-51@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Health Sciences University of Hokkaido
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
the Ethics Committee of School of Rehabilitaion Sciences, Health Sciences University of Hokkaido
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
Tel
0133-23-1211
kyo-reha@hoku-iryo-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
| 2025 | Year | 07 | Month | 24 | 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
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066908
