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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier:
NCT01368640
First received: April 15, 2011
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Bioelectrical Impedance Measurement of Healthy Adults

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Further study details as provided by Seca GmbH & Co. Kg.:

Primary Outcome Measures:
  • Bioelectrical Impedance of 5 and 50 kHz for one body side [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Bioelectrical Impedance of 50 kHz for all 4 extremities [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Generation of prediction equations for Sceletal Muscle Mass based on MRI [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Bioelectrical Impedance in sitting, lying and standing [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Precision Study [ Time Frame: 15 min ] [ Designated as safety issue: No ]

    The precision study pursues three targets:

    1. 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).
    2. Between-operator precision (variability across measurements taken by the same device, but different operators).
    3. Between-device precision (variability across measurements taken by the same operator, but different devices).


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 153
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy adults
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Data of 130 healthy adults are planned to be collected.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368640

Locations
Germany
Institute of Human Nutrition and Food Science
Kiel, Germany, 24105
Sponsors and Collaborators
Seca GmbH & Co. Kg.
Investigators
Principal Investigator: Manfred J. Mueller, Prof. Dr. med. Christian-Albrechts-University of Kiel
  More Information

No publications provided

Responsible Party: Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier: NCT01368640     History of Changes
Other Study ID Numbers: BCA-01
Study First Received: April 15, 2011
Last Updated: October 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 22, 2013