Plain English Summary
Background and study aims
Bioelectrical impedance analysis (BIA) is a commonly used method for estimating body composition, and in particular body fat. Visceral fat is body fat that is stored within the abdominal cavity around internal organs such as the liver, pancreas and intestines. The aim of this study is to test a newly developed standing -posture BIA system to see whether it can accurately measure abdominal visceral fat.
Who can participate?
Healthy Taiwanese adults with normal physical activity
What does the study involve?
The abdominal visceral fat area measured using BIA is compared with the area measured using an abdominal computerized tomography (CT) scan.
What are the possible benefits and risks of participating?
The risks to participants are exposure to radiation during the CT scan, but this is a safe and legal dose.
Where is the study run from?
Dali Jen-Ai Hospital (China)
When is the study starting and how long is it expected to run for?
January 2008 to December 2013
Who is funding the study?
National Science Council of the Republic of China (China)
Who is the main contact?
Dr Kuen-Chang Hsieh
Trial website
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
The 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, 11/05/2010, 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 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 measure
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 (if study stopped)
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
National Chung Hsing University
Taichung 402
402
Taiwan
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
Basic results (scientific)
Publication list