Body CompositionUltraDXANCT03430323
Ultra Dual-Energy X-ray Absorptiometry (DXA): Accurate and Precise Quantitative Multi-compartment Body Composition
An observational study of Body Composition, run by University of California, San Francisco at 1 site in United States.
Trial summary
The central hypothesis is that the combination of measurements from 3D optical scans with standard DXA scans can be used to calculate 4 unique body composition compartments: water, fat, protein, mineral. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2016to Jan 2018
- 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: Community sample
Who may be able to join
- ambulatory
- tolerate lying on their back on a table for 20 minutes
- less than 250 lbs
- tolerate standing and holding still for 1 minute
Who cannot join
- cannot stand for several minutes
- cannot lie down on a table for 10 minutes
- over 250 lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Ultra DXA: Accurate and Precise Quantitative Multi-compartment Body Composition
The central hypothesis is that the combination of measurements from 3D optical scans with standard DXA scans can be used to calculate 4 unique body composition compartments: water, fat, protein, mineral. This is significant because it will allow for accurate assessment of adiposity and functional protein status independent of hydration. The hypothesis is based on preliminary data collected demonstrating the use of thickness and dual energy X-ray measurements to calculate three-compartment breast composition.
Read the detailed description
This is a cross-sectional comparative technology study using a sample of convenience stratified by age, sex, and BMI. Following consent, each participant will undergo:
- 6 DXA whole body scans. The primary measure is bone mineral mass and body volume. DXA body volume is measured using equations from previous work that relate the fat, lean, and bone masses to individual volumes in an image pixel using the physical densities of the components and the know area of the pixel.
- Total body water measurement using standard deuterium dilution methods. The primary measure is total body water in liters.
- Body volume measurement using air displacement plethsymography. The primary measure is volume in liters.
- Whole body 3D optical surface scans. The primary measures mesh points that make up a point cloud of the surface of the body. Approximately 500,000 mesh points are used and placed on the surface of the participants body image. The variation of the location of these mesh points can be described using Principal Component Analysis (PCA). In addition, the 3D optical scans can be used to measure the thickness of the body along the path of each X-ray that goes through the body resulting in a tissue thickness for each DXA image pixel.
- Bioelectrical impedance analysis (BIA). The primary measure is percent body fat, and total body water.
- Physical anthropometry. The primary measure is waist circumference.
- Conditions
- Body Composition
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between BIA and deuterium methods to measure total body water.
Correlation between total body water from deuterated water, versus total body water estimated from BIA. body water is directly reported by the BIA device.
Measured: 1 Day
Relationship between whole body 4-C DXA and standard 4-C body fat
The standard 4-component model combines 4 measures (weight, DXA bone mineral mass, body volume by ADP, and body water using deuterium) into one equation to estimate body fat. The proposed 4C-DXA method estimates pixel by pixel body fat in the DXA image by combining pixel level measures. These measures are the low- and high-energy X-ray absorption of the tissue visualized in the pixel, and the pixel thickness measured using 3D optical tissue thickness. When no bone is present, these three measures provide three estimates of tissue protein, fat, and water. When bone is present, the same measures used to estimate bone, fat, and lean mass where lean is the sum of water and protein masses. The protein/water ratio is estimated from nearest neighbor pixels that contain no bone. This results in a description of the fat, water, protein, and mineral masses of all pixels. Summing the pixels provides total fat. The correlation of the standard to the proposed estimates of body fat is the outcome.
Measured: 1 Day
Secondary outcomes (2)
Associations of 3D optical shape and DXA percent body fat.
Using the mesh points that make up the image data of 3D images, one can estimate body percent fat by treating all mesh points as variables and describing their shape variance using principal component analysis (PCA). The result of the PCA method is that it creates variables that describe the variance of all the mesh points. The PCA variables can then be used to estimate percent body fat. In this secondary outcome, we will compare the estimate of percent body fat using PCA variables to the percent body fat of the standard 4-compartment model.
Measured: 1 Day
Standard 4C fat mass compared to simplified 4C model
In this secondary analysis we compare using correlation statistics the total body fat mass from the standard 4C model to that derived using a simplified whole body 4C model. In the simplified model, BIA-estimated body water is substituted for deuterium-dilution, and a derivation of body volume using DXA for ADP body volume. DXA can estimate body volume by first determining the total fat, lean, and bone reported for a participant, and then using the previously derived physical densities of fat, lean, and bone masses, estimate the total body volume. The singular comparison for this aim is the correlation of standard 4C model body fat to the simplified 4C model body fat.
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 posted12 Feb 2018
- Study start29 Aug 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- John A Shepherd, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430323
- Sponsor's protocol ID
- P0515173
- Acronym
- UltraDXA
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra DXA: Accurate and Precise Quantitative Multi-compartment Body Composition
- ClinicalTrials.gov ID
- NCT03430323
- Acronym / sponsor ID
- UltraDXA / P0515173
- Conditions
- Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
The central hypothesis is that the combination of measurements from 3D optical scans with standard DXA scans can be used to calculate 4 unique body composition compartments: water, fat, protein, mineral. This is significant because it will allow for accurate assessment of adiposity and functional protein status independent of hydration. The hypothesis is based on preliminary data collected demonstrating the use of thickness and dual energy X-ray measurements to calculate three-compartment breast composition.
Detailed description
This is a cross-sectional comparative technology study using a sample of convenience stratified by age, sex, and BMI. Following consent, each participant will undergo:
- 6 DXA whole body scans. The primary measure is bone mineral mass and body volume. DXA body volume is measured using equations from previous work that relate the fat, lean, and bone masses to individual volumes in an image pixel using the physical densities of the components and the know area of the pixel.
- Total body water measurement using standard deuterium dilution methods. The primary measure is total body water in liters.
- Body volume measurement using air displacement plethsymography. The primary measure is volume in liters.
- Whole body 3D optical surface scans. The primary measures mesh points that make up a point cloud of the surface of the body. Approximately 500,000 mesh points are used and placed on the surface of the participants body image. The variation of the location of these mesh points can be described using Principal Component Analysis (PCA). In addition, the 3D optical scans can be used to measure the thickness of the body along the path of each X-ray that goes through the body resulting in a tissue thickness for each DXA image pixel.
- Bioelectrical impedance analysis (BIA). The primary measure is percent body fat, and total body water.
- Physical anthropometry. The primary measure is waist circumference.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- ambulatory
- tolerate lying on their back on a table for 20 minutes
- less than 250 lbs
- tolerate standing and holding still for 1 minute
Key exclusion criteria (3 listed)
- cannot stand for several minutes
- cannot lie down on a table for 10 minutes
- over 250 lbs
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
Relationship between BIA and deuterium methods to measure total body water.
Time frame: 1 Day
Correlation between total body water from deuterated water, versus total body water estimated from BIA. body water is directly reported by the BIA device.
Relationship between whole body 4-C DXA and standard 4-C body fat
Time frame: 1 Day
The standard 4-component model combines 4 measures (weight, DXA bone mineral mass, body volume by ADP, and body water using deuterium) into one equation to estimate body fat. The proposed 4C-DXA method estimates pixel by pixel body fat in the DXA image by combining pixel level measures. These measures are the low- and high-energy X-ray absorption of the tissue visualized in the pixel, and the pixel thickness measured using 3D optical tissue thickness. When no bone is present, these three measures provide three estimates of tissue protein, fat, and water. When bone is present, the same measures used to estimate bone, fat, and lean mass where lean is the sum of water and protein masses. The protein/water ratio is estimated from nearest neighbor pixels that contain no bone. This results in a description of the fat, water, protein, and mineral masses of all pixels. Summing the pixels provides total fat. The correlation of the standard to the proposed estimates of body fat is the outcome.
2 secondary outcomes
Associations of 3D optical shape and DXA percent body fat.
Time frame: 1 Day
Standard 4C fat mass compared to simplified 4C model
Time frame: 1-Day
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 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
John A Shepherd, PhD principal investigator
University of California, San Francisco
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 Body Composition, run by University of California, San Francisco 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 4 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 7 Mar 2019. 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?
Relationship between BIA and deuterium methods to measure total body water. (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 7 Mar 2019.