An observational study in Bioelectrical Impedance Measurement of Healthy Adults, sponsored by Seca GmbH & Co. Kg.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-09.
Sponsored by Seca GmbH & Co. Kg. · Observational
The aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.
Seca GmbH & Co. Kg. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Data of 130 healthy adults are planned to be collected.
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.
Exclusion Criteria:
31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
Time frame: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
Time frame: about 1 hour
Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
BMC is used to calculate Fat Free Mass (FFM). In addition to that Body Volume, Total Body Water (TBW) and Body Weight is needed. DXA is used as reference measurement for Skeletal Muscle Mass (SMM) as well.
Time frame: about 30 minutes
Body Volume based on Air Displacement Plethysmography (ADP)
Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.
Time frame: about 30 minutes
TBW
A D2O dose of 400 mg per kg body weight mixed with tap water is administered orally in the morning fasting and after a 2 hour fluid abstention. The distribution of the stable isotope in the TBW is completed after 4 hours. During this period, the subject remains fasting. Two venous blood samples of 10 ml whole blood are taken immediately before and four hours after taking D2O. The plasma samples are analyzed using Isoptopic Ratio Mass Spectrometry (IRMS).
Time frame: within 4 hours
ECW
Orally administered NaBr is resorbed quickly and completely and almost exclusively distributes in the extracellular compartment. Blood samples of 10 ml are taken immediately before and 4 hours after oral application of 50 mg NaBr per kg body weight. The serum sample is analyzed by X-Ray Fluorescence Spectroscopy (XRF).
Time frame: within 4 hours
Bioelectrical Impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
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.
Time frame: about 1 hour
SMM based on Magnet Resonance Imaging (MRI)
Time frame: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position
Time frame: about 1 hour
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Seca GmbH & Co. Kg.