Condition category
Not Applicable
Date applied
25/07/2012
Date assigned
26/10/2012
Last edited
26/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kuen-Chang Hsieh

ORCID ID

Contact details

Office of Physical Education and Sport
National Chung Hsing University
250 Kuo Kuang Road
Taichung 402
402
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Using computerized tomography to evaluate the foot-to-foot standing bioelectrical impedance analysis device to measure the abdominal visceral fat area

Acronym

Study hypothesis

Our newly developed standing-posture bioelectrical impedance analysis (BIA) system with four-contact electrodes can measure abdominal visceral fat area with accuracy.

Ethics approval

Institutional Review Board (IRB) of Advisory Committee at Jen-Ai Hospital, 11 May 2010 ref: 99-02

Study design

Randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Abdominal visceral fat measurement in healthy volunteers

Intervention

1. Abdominal VFA measurements using a standing BIA system
2. Abdominal VFA measurements using abdominal computerized tomography (CT) scanned at the L4-L5 level

Both of these two measurements were performed subsequently at the same condition.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Abdominal VFA measurements obtained using abdominal computerized tomography (CT) scanned at the L4-L5 level

Secondary outcome measures

Abdominal VFA measurements obtained using a standing BIA system

Overall trial start date

01/01/2008

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy subjects with normal physical activity were selected in Taiwan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

116 females and 154 males

Participant exclusion criteria

1. The participants had no major diseases, such as diabetes, cancer, kidney dysfunction, liver diseases or long-term asthma
2. Pregnant women or women who were likely to become pregnant, menstruating women
3. Individuals with electronic implants (electronic devices attached to the body)

Recruitment start date

01/01/2008

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Taiwan

Trial participating centre

Office of Physical Education and Sport
Taichung 402
402
Taiwan

Sponsor information

Organisation

Charder Electronic Co.Ltd. (Taiwan)

Sponsor details

No.103 Guozhong Rd
Dali District
Taichung
404
Taiwan

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

National Science Council of the Republic of China (China) ref: NSC100-2410-H-028-001-MY3

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes