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Completed

NCT Number: NCT03779932

Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. 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.

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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

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

Inclusion criteria

  • healthy adults in an
  • age range of 18 to 65 years
  • BMI > 30 kg/m2

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
  • extensive tattoos at arms or legs

Treatment and study plan

Primary outcomes

  1. BIA 5 and 50 kHz

    Time frame: 15 minutes

    Bioelectrical Impedance of 5 and 50 kHz for one body side

  2. BIA 50 kHz

    Time frame: 15 minutes

    Bioelectrical Impedance of 50 kHz for all 4 extremities

  3. Total body water

    Time frame: 15 minutes

    Total body water (TBW) by deuterium (D2O) dilution

  4. Extracellular water

    Time frame: 15 minutes

    Extracellular water (ECW) by NaBr dilution

  5. Fat-free mass

    Time frame: 1 hour

    Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight

  6. Skeletal muscle mass

    Time frame: 1 hour

    Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

  7. Visceral adipose tissue

    Time frame: 1 hour

    Visceral adipose tissue VAT by magnetic resonance imaging (MRI)

Secondary outcomes

  1. Complete BIA

    Time frame: 15 minutes

    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 for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.

Sponsors and collaborators

Lead sponsor

Seca GmbH & Co. Kg.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2018
Registry last updated
Jul 24, 2019

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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