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

Completed

• Conditions: Bioelectrical Impedance Measurement of Healthy Adults

• Registration Number: NCT01368640
• Lead Sponsor: Seca GmbH & Co. Kg.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2011-09
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	15 minutes	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	1 hour
Bioelectrical Impedance in sitting, lying and standing	15 minutes
Precision Study	15 min	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).

Trial Locations

Locations (1)

Institute of Human Nutrition and Food Science; 🇩🇪 Kiel, Germany