UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048570 |
|---|---|
| Receipt number | R000055342 |
| Scientific Title | TANITA BIA Validation Study |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2022/11/02 12:01:57 |
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Basic information
Public title
TANITA BIA Validation Study
Acronym
TANITA BIA Validation Study
Scientific Title
TANITA BIA Validation Study
Scientific Title:Acronym
TANITA BIA Validation Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the accuracy and characteristics of the Tanita Body Composition Analyzer algorithm by comparing data from various measurement items with body composition measurements by the Tanita Body Composition Analyzer.
Basic objectives2
Others
Basic objectives -Others
correlation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of visceral fat area data, body fat percentage data, muscle mass data, and bone mass data from mutual medical devices
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women from the ages of 20 and older to below the age of 65 at the time of consent acquisition.
2.Subjects have been fully informed of the purpose and content of the study and who have signed a consent form prior to the start of the study.
3.Subjects are judged by the study investigator to be safe to participate in the study
Key exclusion criteria
1.Subjects undergoing treatment for or with a history of malignancy, heart failure, or myocardial infarction
2.Subjects with implanted pacemakers or implantable cardioverter defibrillators
3.Those under treatment for arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases
4.Pharmaceuticals (including herb.al medicines) ･Persons who regularly use dietary supplements
5.Pregnant, lactating, or intending to become pregnant during the study period
6.Subjects with cochlear implants or cochlear implants
7.Subjects with dental implants
8.A person who is performing nail
9.Other persons who are determined to be unsuitable based on a pre-measurement interview
10.Other subjects deemed inappropriate for this study by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | |
| Last name | Sakamoto |
Organization
Medical Corporation Foundation Ishinkai Kaijo-building Clinic
Division name
Metabolism
Zip code
100-0004
Address
Tokiwabashi Tower 10F,2-6-4 Otemachi, Chiyoda-ku, Tokyo
TEL
03-5685-6245
ysaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD
Division name
CRO Business division
Zip code
103-0027
Address
Front Place Nihonbashi,2-14-1 Nihonbashi, Chuo-ku, Tokyo
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
TANITA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee,Kanazawabunko Hospital
Address
2-6-22 Kamariya Higashi, Kanazawa-ku, Yokohama, Kanagawa
Tel
0570-783-706
h.itou@kanabun-hp.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
| 2022 | Year | 08 | Month | 03 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To confirm the accuracy and characteristics of the Tanita Body Composition Analyzer algorithm by comparing data from various measurement items with body composition measurements by the Tanita Body Composition Analyzer.
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055342
| 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 |
