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Generation of Prediction Equations for BIA of the Elderly

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ClinicalTrials.gov Identifier: NCT04028648
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Seca GmbH & Co. Kg.

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 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.


Condition or disease
Healthy Elderly

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Group/Cohort
elderly
150 elderlies (>60 years): community dwelling or living in old



Primary Outcome Measures :
  1. BIA 5 and 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 5 and 50 kHz for one body side

  2. BIA 50 kHz [ Time Frame: 15 minutes ]
    Bioelectrical Impedance of 50 kHz for all 4 extremities

  3. Total body water [ Time Frame: 15 minutes ]
    Total body water (TBW) by deuterium (D2O) dilution

  4. Extracellular water [ Time Frame: 15 minutes ]
    Extracellular water (ECW) by NaBr dilution

  5. 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

  6. Skeletal muscle mass [ Time Frame: 1 hour ]
    Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)

  7. Visceral adipose tissue [ Time Frame: 1 hour ]
    Visceral adipose tissue (VAT) by magnetic resonance imaging MRI


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
whole blood


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
150 elderlies (>60 years): community dwelling or living in old nursing homes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028648


Contacts
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Contact: Kristin Klückmann +4940200000 ext 232 Kristin.Klueckmann@seca.com

Locations
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Germany
Institute of Human Nutrition and Food Science Recruiting
Kiel, Germany, 24105
Contact: Anja Bosy-Westphal, Prof. Dr. Dr.    0049 431 880 ext 5670    abosyw@nutrfoodsc.uni-kiel.de   
Principal Investigator: Anja Bosy-Westphal, Prof. Dr. Dr.         
Sub-Investigator: Wiebke Braun, Dr.         
Sponsors and Collaborators
Seca GmbH & Co. Kg.

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Responsible Party: Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier: NCT04028648     History of Changes
Other Study ID Numbers: BCA-12
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No