Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

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.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 992

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Institute for Transfusion Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Data of 992 healthy adults are planned to be collected.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	about 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Predicate Device: BIOSPACE INBODY 720	about 15 minutes

Collaborators and Investigators

• Sponsor: Seca GmbH & Co. Kg.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Adults; Bioelectrical Impedance Measurement
• Other Study ID Numbers: BCA-03 | BCA-04