Generation of Normal Ranges 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:
NCT01481285
First received: July 21, 2011
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was 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. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Generation of Normal Ranges 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 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [ Time Frame: about 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.


Secondary Outcome Measures:
  • Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S. [ Time Frame: about 15 minutes ] [ Designated as safety issue: No ]
    Predicate Device: BIOSPACE INBODY 720


Enrollment: 992
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy adults
The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years 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 992 healthy adults are planned to be collected.

Criteria

Inclusion Criteria:

The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".

Exclusion Criteria:

  • amputation of limbs
  • electrical implant as cardiac pacemaker
  • insulin pumps
  • probands who cannot provide an ICF by themselves
  • probands who might be dependent from the sponsor or the inv. site
  • extensive tattoos at arms or legs
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01481285

Locations
Germany
Institute for Transfusion Medicine
Hamburg, Germany, 20246
Sponsors and Collaborators
Seca GmbH & Co. Kg.
Investigators
Principal Investigator: Sven Peine, Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier: NCT01481285     History of Changes
Other Study ID Numbers: BCA-03 | BCA-04
Study First Received: July 21, 2011
Last Updated: October 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Seca GmbH & Co. Kg.:
Bioelectrical Impedance Measurement
Adults

ClinicalTrials.gov processed this record on October 23, 2014