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Completed

NCT Number: NCT04028648

Generation of Prediction Equations for BIA of the Elderly

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.

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Key information

Conditions

Healthy Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Human Nutrition and Food Science

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total Body Water

    Time frame: 15 minutes

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

  2. Extracellular Water

    Time frame: 15 minutes

    Extracellular water (ECW) by NaBr dilution

  3. Fat-free Mass

    Time frame: 15 minutes

    Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight

  4. Skeletal Muscle Mass

    Time frame: 1 hour

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

  5. Visceral Adipose Tissue

    Time frame: 1 hour

    Visceral adipose tissue (VAT) by magnetic resonance imaging MRI

Sponsors and collaborators

Lead sponsor

Seca GmbH & Co. Kg.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2019
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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