Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

July 22, 2019 updated by: Seca GmbH & Co. Kg.

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

The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

38 healthy obese adults

Description

Inclusion Criteria:

  • healthy adults in an
  • age range of 18 to 65 years
  • BMI > 30 kg/m2

Exclusion Criteria:

  • acute and chronic diseases
  • regular intake of medications (except for contraceptives)
  • amputation of limbs
  • electrical implant as cardiac pacemaker
  • insulin pumps
  • artificial joints
  • metallic implants (except tooth implants)
  • claustrophobia
  • pregnancy or breastfeeding period
  • probands who cannot provide an ICF by themselves
  • probands who might be dependent from the sponsor or the inv. site
  • current alcohol abuse
  • frequent hypersensitivity reactions/allergies determ. anamnestically
  • extensive tattoos at arms or legs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIA 5 and 50 kHz
Time Frame: 15 minutes
Bioelectrical Impedance of 5 and 50 kHz for one body side
15 minutes
BIA 50 kHz
Time Frame: 15 minutes
Bioelectrical Impedance of 50 kHz for all 4 extremities
15 minutes
Total body water
Time Frame: 15 minutes
Total body water (TBW) by deuterium (D2O) dilution
15 minutes
Extracellular water
Time Frame: 15 minutes
Extracellular water (ECW) by NaBr dilution
15 minutes
Fat-free mass
Time Frame: 1 hour
Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
1 hour
Skeletal muscle mass
Time Frame: 1 hour
Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
1 hour
Visceral adipose tissue
Time Frame: 1 hour
Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete BIA
Time Frame: 15 minutes
Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seca GmbH & Co. Kg.

Investigators

  • Principal Investigator: Manfred J Müller, Prof. Dr., Christian-Albrechts-University of Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 23, 2015

Primary Completion (ACTUAL)

February 24, 2016

Study Completion (ACTUAL)

February 24, 2016

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • BCA-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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