Development of a new foot-to-foot standing bioelectrical impedance analysis device to measure the abdominal visceral fat
| ISRCTN | ISRCTN44356063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44356063 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/07/2012
- Registration date
- 26/10/2012
- Last edited
- 31/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Office of Physical Education and Sport
National Chung Hsing University
250 Kuo Kuang Road
Taichung 402
402
Taiwan
Study information
| Study design | Randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Using computerized tomography to evaluate the foot-to-foot standing bioelectrical impedance analysis device to measure the abdominal visceral fat area |
| Study objectives | The newly developed standing-posture bioelectrical impedance analysis (BIA) system with four-contact electrodes can measure abdominal visceral fat area with accuracy. |
| Ethics approval(s) | Institutional Review Board (IRB) of Advisory Committee at Jen-Ai Hospital, 11/05/2010, ref: 99-02 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2008 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 116 females and 154 males |
| Key inclusion criteria | Healthy subjects with normal physical activity were selected in Taiwan |
| Key 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) |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
402
Taiwan
Sponsor information
Industry
No.103 Guozhong Rd
Dali District
Taichung
404
Taiwan
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/05/2017: Plain English summary added.
