Clinical trial NCT01471938: Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
Official title: Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioelectrical Impedance Measurement of Healthy Adults
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data of 130 healthy adults are planned to be collected.

Brief summary: The aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.


Eligibility criteria: 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

Primary outcomes:
measure: Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
timeFrame: about 1 hour
measure: Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
timeFrame: about 1 hour
measure: Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
timeFrame: about 30 minutes
measure: Body Volume based on Air Displacement Plethysmography (ADP)
timeFrame: about 30 minutes
measure: TBW
timeFrame: within 4 hours
measure: ECW
timeFrame: within 4 hours
Secondary outcomes:
measure: Bioelectrical Impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
timeFrame: about 1 hour
measure: SMM based on Magnet Resonance Imaging (MRI)
timeFrame: about 1 hour
measure: Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position
timeFrame: about 1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: Body Composition of NY Obesity Research Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Dympna Gallagher, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.