Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Aim of the study is 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.
Bioelectrical Impedance Measurement of Healthy Adults
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)|
- Bioelectrical Impedance of 5 and 50 kHz for one body side [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- Bioelectrical Impedance of 50 kHz for all 4 extremities [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]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.
- Generation of prediction equations for Sceletal Muscle Mass based on MRI [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Bioelectrical Impedance in sitting, lying and standing [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- Precision Study [ Time Frame: 15 min ] [ Designated as safety issue: No ]
The precision study pursues three targets:
- Repeatability (variability across successive measurements within a short time period taken by the same operator and the same device; device is repositioned between successive measurements).
- Between-operator precision (variability across measurements taken by the same device, but different operators).
- Between-device precision (variability across measurements taken by the same operator, but different devices).
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368640
|Institute of Human Nutrition and Food Science|
|Kiel, Germany, 24105|
|Principal Investigator:||Manfred J. Mueller, Prof. Dr. med.||Christian-Albrechts-University of Kiel|