Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups

Study Overview
=================
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.

Official Title
-----------------
Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups

Conditions
-----------------
Bioelectrical Impedance Measurement of Healthy Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caucasians<br>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. | |
| Afro Americans<br>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. | |
| East and Southeast Asian<br>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. | |
| Hispanics<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 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. | 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). | 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). | within 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | about 1 hour | 
| 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 |