Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01368640

Enrollment

153

Registered

2011-06-08

Start date

2011-04-30

Completion date

2012-08-31

Last updated

2012-10-03

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

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Brief summary

Aim of the study is 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.

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 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
Bioelectrical Impedance of 5 and 50 kHz for one body side	15 minutes
Bioelectrical Impedance of 50 kHz for all 4 extremities	15 minutes

Secondary

Measure	Time frame	Description
Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz	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.
Generation of prediction equations for Sceletal Muscle Mass based on MRI	1 hour	—
Bioelectrical Impedance in sitting, lying and standing	15 minutes	—
Precision Study	15 min	The precision study pursues three targets: 1. Repeatability (variability across successive measurements within a short time period taken by the same operator and the same device; device is repositioned between successive measurements). 2. Between-operator precision (variability across measurements taken by the same device, but different operators). 3. Between-device precision (variability across measurements taken by the same operator, but different devices).

Countries

Germany

Outcome results