Generation of Prediction Equations for BIA of the Elderly

NCT ID: NCT04028648

Last Updated: 2022-02-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2020-01-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Elderly

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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elderly

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seca GmbH & Co. Kg.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Human Nutrition and Food Science

Kiel, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36933351 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BCA-12

Identifier Type: -

Identifier Source: org_study_id

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