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.
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
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:
- You are between the ages of 18 and 99 years old
- You declare that you are healthy and do not have any known disease condition
- You are not pregnant
- You do not have an implanted electrical defibrillator
- 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.
- Conditions
- Self-declared Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted27 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-declared Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IPGDx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hank C Lukaski, PhD, Principal investigator
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bioimpedance Body Composition Device Measurements: Predicate (EFG®) Versus Candidate (Vitality Analyzer™)
- ClinicalTrials.gov ID
- NCT01888068
- Acronym / sponsor ID
- IPGDx_Protocol1
- Conditions
- Self-declared Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IPGDx, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- You are between the ages of 18 and 99 years old
- You declare that you are healthy and do not have any known disease condition
- You are not pregnant
- You do not have an implanted electrical defibrillator
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Self declared healthy subjects aged 18 to 99
Key inclusion criteria (2 listed)
- self-reported healthy men and women
- 18 to 99 years of age
Key exclusion criteria (3 listed)
- Pregnancy
- Pacemaker
- Implanted Electrical Defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hank C Lukaski, PhD principal investigator
2 sites in 1 country: see every site and its status.
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.