Generation of Prediction Equations for BIA of the Elderly

Healthy Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028648
• Other study ID #: BCA-12
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: October 2021
• Source: Seca GmbH & Co. Kg.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Elderly

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition and Food Science	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Seca GmbH & Co. Kg.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Body Water	Total body water (TBW) by deuterium (D2O) dilution	15 minutes
Primary	Extracellular Water	Extracellular water (ECW) by NaBr dilution	15 minutes
Primary	Fat-free Mass	Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight	15 minutes
Primary	Skeletal Muscle Mass	Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)	1 hour
Primary	Visceral Adipose Tissue	Visceral adipose tissue (VAT) by magnetic resonance imaging MRI	1 hour