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Completed

NCT Number: NCT01471938

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

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.

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Key information

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Body Composition of NY Obesity Research Center

New York, 10025, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: about 1 hour

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

    Time frame: about 1 hour

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

    Time frame: about 30 minutes

    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.

  4. Body Volume based on Air Displacement Plethysmography (ADP)

    Time frame: about 30 minutes

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

  5. TBW

    Time frame: within 4 hours

    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).

  6. ECW

    Time frame: within 4 hours

    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).

Secondary outcomes

  1. 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

    Time frame: about 1 hour

    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.

  2. SMM based on Magnet Resonance Imaging (MRI)

    Time frame: about 1 hour

  3. Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position

    Time frame: about 1 hour

Sponsors and collaborators

Lead sponsor

Seca GmbH & Co. Kg.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2011
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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