Clinical trial NCT04028648: Generation of Prediction Equations for BIA of the Elderly
Official title: Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Elderly
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2019-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 150 elderlies (\>60 years): community dwelling or living in old nursing homes

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.


Eligibility 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

Primary outcomes:
measure: Total Body Water
timeFrame: 15 minutes
measure: Extracellular Water
timeFrame: 15 minutes
measure: Fat-free Mass
timeFrame: 15 minutes
measure: Skeletal Muscle Mass
timeFrame: 1 hour
measure: Visceral Adipose Tissue
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition and Food Science
Study officials:
References: