Validation StudyInBodyNCT02635958
InBody Validation Study
An observational study of Validation Study, run by Mayo Clinic at 1 site in United States.
Trial summary
With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Study
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.
Who may be able to join
- Between 18 and 65 years of age
- Have a Body Mass Index ≥ 18.5 kg/m2
Who cannot join
- Are not English speaking
- Are younger than 18 years of age
- Weigh more than 450 lbs
- Taller than 6'6" due to size constraints of the iDXA
- Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
- People having radioactive iodine thyroid treatment.
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- People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
- People with large amounts of metal in their bodies.
- People with arthritis of the spine recorded in the medical record.
- Are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the InBody 770® for the Assessment of Body Composition
With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.
Read the detailed description
This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.
- Conditions
- Validation Study
- Keywords
- Body Mass Index, BMI, InBody, iDXA, validation
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 |
|---|---|---|
| Group 1 | BMI 18.5 to 24.9 | |
| Group 2 | BMI 25 to 29.9 | |
| Group 3 | BMI 30 to 34.9 | |
| Group 4 | BMI ≥ 35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition Measures
compare body composition measures between InBody and iDXA
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- BioSpace, Inc.
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ryan T Hurt, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635958
- Sponsor's protocol ID
- 14-004659
- Acronym
- InBody
- Status last verified
- May 2020
- First submitted
- 17 Dec 2015
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the InBody 770® for the Assessment of Body Composition
- ClinicalTrials.gov ID
- NCT02635958
- Acronym / sponsor ID
- InBody / 14-004659
- Conditions
- Validation Study
- Keywords
- Body Mass Index, BMI, InBody, iDXA, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- BioSpace, Inc.
- Study start
- Dec 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Dec 2015 (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.
With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.
Detailed description
This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –BMI 18.5 to 24.9 |
| Group 2 | – | –BMI 25 to 29.9 |
| Group 3 | – | –BMI 30 to 34.9 |
| Group 4 | – | –BMI ≥ 35 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.
Key inclusion criteria (2 listed)
- Between 18 and 65 years of age
- Have a Body Mass Index ≥ 18.5 kg/m2
Key exclusion criteria (10 listed)
- Are not English speaking
- Are younger than 18 years of age
- Weigh more than 450 lbs
- Taller than 6'6" due to size constraints of the iDXA
- Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
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
Body Composition Measures
Time frame: 1 day
compare body composition measures between InBody and iDXA
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 Jun 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Ryan T Hurt, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Study, run by Mayo Clinic at 1 site 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 10 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Body Composition Measures (time frame: 1 day). 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 Jun 2020.