UMIN-CTR Clinical Trial

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
Email	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
Email	food-contact@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055342