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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01481285

Enrollment

992

Registered

2011-11-29

Start date

2011-10-31

Completion date

2012-01-31

Last updated

2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioelectrical Impedance Measurement, Adults

Brief summary

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.

Interventions

None listed

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 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

Design outcomes

Primary

Measure	Time frame	Description
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	about 15 minutes	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.

Secondary

Measure	Time frame	Description
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.	about 15 minutes	Predicate Device: BIOSPACE INBODY 720

Countries

Germany

Outcome results