Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
- Conditions
- Healthy
- Registration Number
- NCT01481285
- Lead Sponsor
- Seca GmbH & Co. Kg.
- Brief Summary
The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 992
The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
- probands who cannot provide an ICF by themselves
- probands who might be dependent from the sponsor or the inv. site
- extensive tattoos at arms or legs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz about 15 minutes The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are planned to be measured.
- Secondary Outcome Measures
Name Time Method Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S. about 15 minutes Predicate Device: BIOSPACE INBODY 720
Trial Locations
- Locations (1)
Institute for Transfusion Medicine
🇩🇪Hamburg, Germany