Generation of Prediction Equations for BIA of the Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Elderly

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Institute of Human Nutrition and Food Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Body Water	Total body water (TBW) by deuterium (D2O) dilution	15 minutes
Extracellular Water	Extracellular water (ECW) by NaBr dilution	15 minutes
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
Skeletal Muscle Mass	Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)	1 hour
Visceral Adipose Tissue	Visceral adipose tissue (VAT) by magnetic resonance imaging MRI	1 hour

Collaborators and Investigators

• Sponsor: Seca GmbH & Co. Kg.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BCA-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No