Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Study Overview
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Brief Summary
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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.

Official Title
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Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy adults<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Predicate Device: BIOSPACE INBODY 720 | about 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioelectrical Impedance Measurement, Adults