Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

Bioelectrical Impedance Measurement of Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779932
• Other study ID #: BCA-20
• Status: Completed
• Start date: February 23, 2015
• Est. completion date: February 24, 2016

Study information

• Verified date: December 2018
• Source: Seca GmbH & Co. Kg.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 24, 2016
• Est. primary completion date: February 24, 2016
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy adults in an

• age range of 18 to 65 years

• BMI > 30 kg/m2

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

• extensive tattoos at arms or legs

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	BIA 5 and 50 kHz	Bioelectrical Impedance of 5 and 50 kHz for one body side	15 minutes
Primary	BIA 50 kHz	Bioelectrical Impedance of 50 kHz for all 4 extremities	15 minutes
Primary	Total body water	Total body water (TBW) by deuterium (D2O) dilution	15 minutes
Primary	Extracellular water	Extracellular water (ECW) by NaBr dilution	15 minutes
Primary	Fat-free mass	Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight	1 hour
Primary	Skeletal muscle mass	Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)	1 hour
Primary	Visceral adipose tissue	Visceral adipose tissue VAT by magnetic resonance imaging (MRI)	1 hour
Secondary	Complete BIA	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 for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.	15 minutes