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

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.

Study Overview

• Status: Completed
• Conditions: Bioelectrical Impedance Measurement of Healthy Adults

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Institute of Human Nutrition and Food Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Data of 130 healthy adults are planned to be collected.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioelectrical Impedance of 5 and 50 kHz for one body side	15 minutes
Bioelectrical Impedance of 50 kHz for all 4 extremities	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	15 minutes
Generation of prediction equations for Sceletal Muscle Mass based on MRI		1 hour
Bioelectrical Impedance in sitting, lying and standing		15 minutes
Precision Study	The precision study pursues three targets: 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).; Between-operator precision (variability across measurements taken by the same device, but different operators).; Between-device precision (variability across measurements taken by the same operator, but different devices).	15 min

Collaborators and Investigators

• Sponsor: Seca GmbH & Co. Kg.
• Investigators: Principal Investigator: Manfred J. Mueller, Prof. Dr. med., Christian-Albrechts-University of Kiel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: BCA-01