Generation of Prediction Equations for BIA of the Elderly

Overview

The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand.

Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.

Full Title of Study: “Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: February 28, 2020

Arms, Groups and Cohorts

  • elderly
    • 150 elderlies (>60 years): community dwelling or living in old

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Complete BIA
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • male and female subjects older than 60 years,
  • stable medication (no changes during the past 6 months),
  • subjects need to be able to sign the informed consent and privacy policy

Exclusion Criteria

  • acute disease
  • intake of diuretics
  • wearing of support stockings
  • edema diagnosed by inspection and palpation of lower limbs
  • paralysis e.g. after a stroke
  • neurodegenerative diseases e.g. ALS
  • tumors in treatment
  • amputation
  • electronic implants e.g. pacemaker
  • under the skin applied injection systems (e.g. insulin pumps or pain pumps)
  • probands who cannot provide an ICF by themselves
  • probands who might be dependent from the sponsor or the investigation site
  • current alcohol abuse
  • active prostheses
  • electronic life-support systems, e.g. artificial heart, artificial lung
  • portable electronic medical devices, e.g. ECG devices or infusion pumps
  • metallic implants
  • cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis)
  • vessel clips in the brain or medulla applied before 1995
  • defeatable pumps
  • catheter
  • iron or metallic parts in the body (e.g. shard of metal)
  • dental braces
  • magnetic tooth implants
  • not removeable piercings
  • extensive tattoos

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seca GmbH & Co. Kg.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Kristin Kl├╝ckmann, +4940200000, Kristin.Klueckmann@seca.com

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