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CompletedNCT03779932Updated Jul 24, 2019

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

An observational study in Bioelectrical Impedance Measurement of Healthy Adults, sponsored by Seca GmbH & Co. Kg.. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Seca GmbH & Co. Kg. · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
38
Ages
18 Years to 65 Years
Sex
All
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Study summary

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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Conditions studied

  • Bioelectrical Impedance Measurement of Healthy Adults
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In context

Lead sponsor

Seca GmbH & Co. Kg. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

38 healthy obese adults

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
38 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. BIA 5 and 50 kHz

    Bioelectrical Impedance of 5 and 50 kHz for one body side

    Time frame: 15 minutes

  2. BIA 50 kHz

    Bioelectrical Impedance of 50 kHz for all 4 extremities

    Time frame: 15 minutes

  3. Total body water

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

    Time frame: 15 minutes

  4. Extracellular water

    Extracellular water (ECW) by NaBr dilution

    Time frame: 15 minutes

  5. Fat-free mass

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

    Time frame: 1 hour

  6. Skeletal muscle mass

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

    Time frame: 1 hour

  7. Visceral adipose tissue

    Visceral adipose tissue VAT by magnetic resonance imaging (MRI)

    Time frame: 1 hour

Secondary outcomes

  1. Complete BIA

    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.

    Time frame: 15 minutes

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Study locations

1 site
  • Institute of Human Nutrition and Food Science
    Kiel, 24105, Germany
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References and documents

Publications

  • Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30. PubMed 32977906 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03779932
Lead sponsor
Seca GmbH & Co. Kg.
Responsible party
Sponsor
First posted
Dec 19, 2018
Start date
Feb 23, 2015
Primary completion
Feb 24, 2016
Completion
Feb 24, 2016
Last update
Jul 24, 2019

Study contacts

Manfred J Müller, Prof. Dr.
principal investigator · Christian-Albrechts-University of Kiel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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