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Completed

NCT Number: NCT01368640

Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Aim of the study is 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.

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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

Institute of Human Nutrition and Food Science

Kiel, 24105, Germany

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 of 5 and 50 kHz for one body side

    Time frame: 15 minutes

  2. Bioelectrical Impedance of 50 kHz for all 4 extremities

    Time frame: 15 minutes

Secondary outcomes

  1. Bioelectrical Impedance 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: 15 minutes

    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. Generation of prediction equations for Sceletal Muscle Mass based on MRI

    Time frame: 1 hour

  3. Bioelectrical Impedance in sitting, lying and standing

    Time frame: 15 minutes

  4. Precision Study

    Time frame: 15 min

    The precision study pursues three targets:

    • Repeatability (variability across successive measurements within a short time period taken by the same operator and the same device; device is repositioned between successive measurements).
    • Between-operator precision (variability across measurements taken by the same device, but different operators).
    • Between-device precision (variability across measurements taken by the same operator, but different devices).

Sponsors and collaborators

Lead sponsor

Seca GmbH & Co. Kg.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 8, 2011
Registry last updated
Oct 3, 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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