Status:

COMPLETED

Generation of Prediction Equations for BIA of the Elderly

Lead Sponsor:

Seca GmbH & Co. Kg.

Conditions:

Healthy Elderly

Eligibility:

All Genders

60+ years

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 22 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 8 2020

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT04028648

Start Date

January 22 2019

End Date

January 8 2020

Last Update

February 14 2022

Active Locations (1)

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Institute of Human Nutrition and Food Science

Kiel, Germany, 24105