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

Bioelectrical Impedance Measurement of Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471938
• Other study ID #: BCA-02
• Status: Completed
• Phase: N/A
• First received: July 8, 2011
• Last updated: February 8, 2012
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Seca GmbH & Co. Kg.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bioelectrical Impedance Measurement of Healthy Adults

Locations

Country	Name	City	State
United States	Body Composition of NY Obesity Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Seca GmbH & Co. Kg.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side		about 1 hour	No
Primary	Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities		about 1 hour	No
Primary	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.	about 30 minutes	No
Primary	Body Volume based on Air Displacement Plethysmography (ADP)	Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.	about 30 minutes	No
Primary	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).	within 4 hours	No
Primary	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).	within 4 hours	No
Secondary	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	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.	about 1 hour	No
Secondary	SMM based on Magnet Resonance Imaging (MRI)		about 1 hour	No
Secondary	Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position		about 1 hour	No