Bioelectrical Impedance Measurement of Healthy Adults
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Seca GmbH & Co. Kg.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
* acute and chronic diseases * regular intake of medications (except for contraceptives) * amputation of limbs * electrical implant as cardiac pacemaker * insulin pumps * artificial joints * metallic implants (except tooth implants) * claustrophobia * pregnancy or breastfeeding period * probands who cannot provide an ICF by themselves * probands who might be dependent from the sponsor or the inv. site * current alcohol abuse * frequent hypersensitivity reactions/allergies determ. anamnestically * body weight of more than 150 kg * extensive tattoos at arms or legs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECW | within 4 hours | 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). |
| Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry) | about 30 minutes | 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. |
| Body Volume based on Air Displacement Plethysmography (ADP) | about 30 minutes | Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight. |
| TBW | within 4 hours | 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). |
| Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side | about 1 hour | — |
| Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities | about 1 hour | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SMM based on Magnet Resonance Imaging (MRI) | about 1 hour | — |
| Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position | about 1 hour | — |
| 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 | about 1 hour | 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. |
Countries
United States
Outcome results
None listed