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

Seca

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT01481285

BCA-03 | BCA-04

Details and patient eligibility

About

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.

Enrollment: 992 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

992 participants in 1 patient group

healthy adults

Description:

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.