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Self-declared Healthy SubjectsNCT01888068

Comparison of Bioimpedance Body Composition Device Measurements

An observational study of Self-declared Healthy Subjects, run by IPGDx, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Self-declared Healthy Subjects
How many people
100 participants
Where
2 sitesUnited States
Study dates
Jun 2013to Jul 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Self declared healthy subjects aged 18 to 99

Who may be able to join

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

Who cannot join

  • Pregnancy
  • Pacemaker
  • Implanted Electrical Defibrillator

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • IPGDx, LLC

    Harrisville, Michigan, 48740

  • FL Arm

    Nokomis, Florida, 34275

Other trials in United States

About this study

Official title: Comparison of Bioimpedance Body Composition Device Measurements: Predicate (EFG®) Versus Candidate (Vitality Analyzer™)

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.

Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01888068
Study groupRoleWhat they receive
No treatmentNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison between the measured results of the candidate and predicate devices

    Measured results from the candidate and predicate devices will be collected and compared

    Measured: One time thirty minute enrollment for two measurements

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888068
Sponsor's protocol ID
IPGDx_Protocol1
Status last verified
Jul 2013
First submitted
25 Jun 2013
Last updated
1 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Self-declared Healthy Subjects, run by IPGDx, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between the measured results of the candidate and predicate devices (time frame: One time thirty minute enrollment for two measurements). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.

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