Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Bioimpedance Body Composition Device Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888068
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
IPGDx, LLC

Brief Summary:
A new investigational device (BIA/Vitality Analyzer™) is being compared to a United States Food and Drug Approved 'predicate' reference device (EFG®) to demonstrate that they provide equivalent measurements of body fat. Both devices are "over-the-counter" bioimpedance body composition analyzers (estimate of body fat). These devices are classified as 'Not Significant Risk' devices; they do not expose you to any significant risks.

Condition or disease
Self-declared Healthy Subjects

Detailed Description:

You will be asked if you are 'healthy' to help the sub-investigator decide if you can be in the study. This is part of the "screening" process.

If you are 'healthy,' you will be asked to read and sign the informed consent documents and then enter into the study. The study Sub-investigator will ask your age, standing height and body weight. This information is used to describe the study participants. You will lie down on a flat surface/table; remove your shoes, socks and any jewelry. Four adhesive electrodes will be attached to your right hand and foot (two on each hand and foot), a small clip will then be connected to each electrode. A low level, radiofrequency alternating electrical current (425 microamps at 50 kilohertz) will be introduced into one pair (hand and foot) and the voltage across your body will be measured (other hand and foot). You will not feel the current being introduced into your body. While you remain on the table, the test will be repeated with a second bioimpedance device. The time required to complete these tests is about fifteen minutes. Participation in this study will depend upon if you are healthy and meet the specific study guidelines.

Screening for this study includes:

  1. You are between the ages of 18 and 99 years old
  2. You declare that you are healthy and do not have any known disease condition
  3. You are not pregnant
  4. You do not have an implanted electrical defibrillator
  5. You do not have a pacemaker

The method for determining body impedance is based on the conduction of an applied electrical current in the organism. In biological structures, application of a constant low-level alternating current results in an impedance to the spread of the current that is frequency dependent. The living organism contains intra- and extracellular fluids that behave as electrical conductors and cell membranes that act as electrical condensers and are regarded as imperfect reactive elements. At low frequencies (-1 kHz) the current mainly passes through the extracellular fluids, whereas at higher frequencies (50-800 kHz), it penetrates the intra- and extracellular fluids. Thus body fluids and electrolytes are responsible for electrical conductance, which is the inverse of resistance, and cell membranes are involved in capacitance.

In biological systems, electrical conduction is related to water and ionic distribution in the conductor. Because fat-free mass, which includes the protein matrix of adipose tissue, contains virtually all the water and conducting electrolytes in the body, conductivity is far greater in the fat-free mass than the fat mass of the body. This hypothetical relationship was proposed by Nyboer et al., who demonstrated that electrically determined biological volumes (V) were inversely related to resistance (R), and reactance (Xc). Because the magnitude of reactance is small relative to resistance, and resistance is a better predictor of impedance than is reactance, the expression for V becomes: V = pL2/R, where R is in ohms.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparison of Bioimpedance Body Composition Device Measurements: Predicate (EFG®) Versus Candidate (Vitality Analyzer™)
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Group/Cohort
No treatment



Primary Outcome Measures :
  1. Comparison between the measured results of the candidate and predicate devices [ Time Frame: One time thirty minute enrollment for two measurements ]
    Measured results from the candidate and predicate devices will be collected and compared


Biospecimen Retention:   None Retained
None acquired or retained


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Self declared healthy subjects aged 18 to 99
Criteria

Inclusion Criteria:

  • self-reported healthy men and women
  • 18 to 99 years of age

Exclusion Criteria:

  • Pregnancy
  • Pacemaker
  • Implanted Electrical Defibrillator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888068


Locations
Layout table for location information
United States, Florida
FL Arm
Nokomis, Florida, United States, 34275
United States, Michigan
IPGDx, LLC
Harrisville, Michigan, United States, 48740
Sponsors and Collaborators
IPGDx, LLC
Investigators
Layout table for investigator information
Principal Investigator: Hank C Lukaski, PhD
Layout table for additonal information
Responsible Party: IPGDx, LLC
ClinicalTrials.gov Identifier: NCT01888068    
Other Study ID Numbers: IPGDx_Protocol1
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013