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

Completed

• Conditions: Bioelectrical Impedance Measurement of Healthy Adults

• Registration Number: NCT03779932
• Lead Sponsor: Seca GmbH & Co. Kg.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Primary Completion: 2016-02-24
• Study Completion: 2016-02-24
• Status Verified: 2018-12
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complete BIA	15 minutes	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.

Trial Locations

Locations (1)

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