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

Bioelectrical Impedance Measurement of Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368640
• Other study ID #: BCA-01
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: October 2, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Seca GmbH & Co. Kg.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: August 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bioelectrical Impedance Measurement of Healthy Adults

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition and Food Science	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Seca GmbH & Co. Kg.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioelectrical Impedance of 5 and 50 kHz for one body side		15 minutes	No
Primary	Bioelectrical Impedance of 50 kHz for all 4 extremities		15 minutes	No
Secondary	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	No
Secondary	Generation of prediction equations for Sceletal Muscle Mass based on MRI		1 hour	No
Secondary	Bioelectrical Impedance in sitting, lying and standing		15 minutes	No
Secondary	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	No