Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Sponsor

Seca GmbH & Co. Kg. (Industry)

Overall Status

Completed

CT.gov ID

NCT01481285

Collaborator

(none)

992

Enrollment

Location

Duration (Months)

328.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was 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. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.

Condition or Disease	Intervention/Treatment	Phase
Healthy

Study Design

Study Type:

Observational

Actual Enrollment :

992 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
healthy adults The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited.

Outcome Measures

Primary Outcome Measures

Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [about 15 minutes]
The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are planned to be measured.

Secondary Outcome Measures

Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S. [about 15 minutes]
Predicate Device: BIOSPACE INBODY 720

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".

Exclusion Criteria:

amputation of limbs
electrical implant as cardiac pacemaker
insulin pumps
probands who cannot provide an ICF by themselves
probands who might be dependent from the sponsor or the inv. site
extensive tattoos at arms or legs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Transfusion Medicine	Hamburg		Germany	20246

Sponsors and Collaborators

Seca GmbH & Co. Kg.

Investigators

Principal Investigator: Sven Peine, Dr., Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seca GmbH & Co. Kg.

ClinicalTrials.gov Identifier:

NCT01481285

Other Study ID Numbers:

BCA-03 | BCA-04

First Posted:

Nov 29, 2011

Last Update Posted:

Oct 4, 2012

Last Verified:

Oct 1, 2012

Keywords provided by Seca GmbH & Co. Kg.

Bioelectrical Impedance Measurement

Adults

Study Results

No Results Posted as of Oct 4, 2012