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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048570
Receipt No. R000055342
Scientific Title TANITA BIA Validation Study
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03

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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) ´ŻąPersons 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 Preinitiation
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 10 Month 17 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 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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