Generation of Prediction Equations for BIA of the Elderly

Completed

• Conditions: Healthy Elderly

• Registration Number: NCT04028648
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-14
• Study Start: 2019-01-22
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Status Verified: 2021-10
• Results First Submitted: 2021-10-06
• Results First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Results First Posted: 2022-02-14
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Human Nutrition and Food Science; 🇩🇪 Kiel, Germany