Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups

N/ACompletedNCT01471938

Seca GmbH & Co. Kg.130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Body Composition of NY Obesity Research Center

New York, New York, United States

Outcomes

Primary Outcomes

Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side

Time frame: about 1 hour

Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities

Time frame: about 1 hour

Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)

BMC is used to calculate Fat Free Mass (FFM). In addition to that Body Volume, Total Body Water (TBW) and Body Weight is needed. DXA is used as reference measurement for Skeletal Muscle Mass (SMM) as well.

Time frame: about 30 minutes

Body Volume based on Air Displacement Plethysmography (ADP)

Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.

Time frame: about 30 minutes

TBW

A D2O dose of 400 mg per kg body weight mixed with tap water is administered orally in the morning fasting and after a 2 hour fluid abstention. The distribution of the stable isotope in the TBW is completed after 4 hours. During this period, the subject remains fasting. Two venous blood samples of 10 ml whole blood are taken immediately before and four hours after taking D2O. The plasma samples are analyzed using Isoptopic Ratio Mass Spectrometry (IRMS).

Time frame: within 4 hours

ECW

Orally administered NaBr is resorbed quickly and completely and almost exclusively distributes in the extracellular compartment. Blood samples of 10 ml are taken immediately before and 4 hours after oral application of 50 mg NaBr per kg body weight. The serum sample is analyzed by X-Ray Fluorescence Spectroscopy (XRF).

Time frame: within 4 hours

Secondary Outcomes

Data from ClinicalTrials.gov

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