Bioelectrical Impedance Measurement of Healthy Adults
Conditions
Keywords
mBCA 555
Brief summary
The mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations (BCA-01, BCA-02, BCA-20) to generate prediction equations for calculating body composition (FFM, SMM, ECW, TBW and VAT) in different populations. Furthermore, normal ranges for body composition were generated based on the previous study BCA-03 conducted at the UKE. The mBCA 555 is a new body composition analyzer measuring bioimpedance in standing position developed by seca. In order to apply prediction equations and normal ranges from previous clinical investigations BCA-01, BCA-02, BCA-03 and BCA-20 to the new mBCA 555 it shall be compared to the mBCA 515.
Detailed description
The use of bioelectrical impedance analysis (BIA) is widespread both in healthy subjects and patients. BIA allows the determination of the fat-free mass (FFM), skeletal muscle mass (SMM), fat mass (FM), extracellular water (ECW) and total body water (TBW) when using appropriate population, age or pathology-specific BIA equations and established procedures. BIA equations are based on validation studies where BIA is compared with reference methods such as Air Displacement Plethysmography (ADP), Dual-Energy X-Ray Absorptiometry (DXA), Magnetic Resonance Imaging (MRI) and isotope dilution. The predicate device seca mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations in Kiel (Germany) and New York City (USA) to generate prediction equations for calculating body composition (FFM, SMM, ECW, TBW and VAT) in different populations. Furthermore, normal ranges for body composition were generated in a previous study conducted at the University Hospital Hamburg-Eppendorf. The mBCA 555 is a new body composition analyzer measuring bioimpedance in standing position developed by seca. Primary objective is to test whether the mBCA 515 prediction equations can be applied to the new mBCA 555. If necessary, to proof substantial equivalence, prediction equations should be adjusted for the mBCA 555. Secondary objective is to compare Impedance, phase angle, reactance and resistance for different frequencies in order to clarify if normal ranges for BIVA and phase angle generated with the mBCA 515 need to be adjusted for the new mBCA 555. Bioimpedance was measured using the seca mBCA 555 and mBCA 515. Body height was measured using the seca 274.
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 No maximum
Inclusion criteria
* male and female subjects, * 18 years and older, * subjects need to be able to sign the informed consent and privacy policy
Exclusion criteria
* acute disease * pregnancy * intake of diuretics * edema diagnosed by inspection and palpation of lower limbs * paralysis e.g. after a stroke * neurodegenerative diseases e.g. ALS * tumors in treatment * amputation * electronic implants e.g. pacemaker * probands who cannot provide an ICF by themselves * probands who might be dependent from the sponsor or the investigation site * current alcohol abuse * active prostheses * electronic life-support systems, e.g. artificial heart, artificial lung * portable electronic medical devices, e.g. ECG devices or infusion pumps * metallic implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SMM | 10min | Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase Angle | 10 minutes | Phase angle at 50 kHz, bias of mBCA 555 in comparison to mBCA 515 |
Other
| Measure | Time frame | Description |
|---|---|---|
| R50RS | 5 minutes | resistance right body side, 50 kHz, bias of mBCA 555 in comparison to mBCA 515 |
| R5RS | 5 minutes | resistance right body side, 5 kHz, bias of mBCA 555 in comparison to mBCA 515 |
Countries
Germany
Participant flow
Recruitment details
Subjects were recruited at the blood donor service of the Institute of Transfusion Medicine. All subjects needed to be suitable for blood donation according to Hämotherapie-Richtlinien nach §§ 12 a und 18 TFG, chapter 2.1.4. Blood donation was conducted after study examinations.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Blood Donors single arm study with healthy blood donors | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | Healthy Blood Donors |
|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 119 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 62 Participants |
| weight | 78.0 kg STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
SMM
Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515
Time frame: 10min
Population: healthy blood donors
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Blood Donors | SMM | 0.34 kg | Standard Deviation 0.44 |
Secondary
Phase Angle
Phase angle at 50 kHz, bias of mBCA 555 in comparison to mBCA 515
Time frame: 10 minutes
Population: healthy blood donors
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Blood Donors | Phase Angle | 0.080 Degree | Standard Error 0.079 |
Other Pre-specified
R50RS
resistance right body side, 50 kHz, bias of mBCA 555 in comparison to mBCA 515
Time frame: 5 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Blood Donors | R50RS | -1.9 Ohm | Standard Deviation 5.15 |
Other Pre-specified
R5RS
resistance right body side, 5 kHz, bias of mBCA 555 in comparison to mBCA 515
Time frame: 5 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Blood Donors | R5RS | -3.05 Ohm | Standard Deviation 6.12 |