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

NCT03779932 | Completed

• 1 other identifier: BCA-20
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Outcome Measures

Primary Outcomes (7)

• BIA 5 and 50 kHz

  Bioelectrical Impedance of 5 and 50 kHz for one body side

  15 minutes

• BIA 50 kHz

  Bioelectrical Impedance of 50 kHz for all 4 extremities

  15 minutes

• Total body water

  Total body water (TBW) by deuterium (D2O) dilution

  15 minutes

• Extracellular water

  Extracellular water (ECW) by NaBr dilution

  15 minutes

• 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

• Skeletal muscle mass

  Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

  1 hour

• Visceral adipose tissue

  Visceral adipose tissue VAT by magnetic resonance imaging (MRI)

  1 hour

Secondary Outcomes (1)

• Complete BIA

  15 minutes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

38 healthy obese adults

You may qualify if:

• healthy adults in an
• age range of 18 to 65 years
• BMI \> 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Seca GmbH & Co. Kg.: lead

Study Sites (1)

Institute of Human Nutrition and Food Science

Kiel, 24105, Germany

Location

Related Publications (2)

• Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9.

  PMID: 36933351 DERIVED

• 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.

  PMID: 32977906 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Manfred J Müller, Prof. Dr.

  Christian-Albrechts-University of Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: February 23, 2015
• Primary Completion: February 24, 2016
• Study Completion: February 24, 2016
• Last Updated: July 24, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)