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Clinical Trials/NCT03430323
NCT03430323
Completed
Not Applicable

Ultra DXA: Accurate and Precise Quantitative Multi-compartment Body Composition

University of California, San Francisco1 site in 1 country33 target enrollmentAugust 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Composition
Sponsor
University of California, San Francisco
Enrollment
33
Locations
1
Primary Endpoint
Relationship between BIA and deuterium methods to measure total body water.
Status
Completed
Last Updated
7 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
August 29, 2016
End Date
January 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ambulatory
  • tolerate lying on their back on a table for 20 minutes
  • less than 250 lbs
  • tolerate standing and holding still for 1 minute

Exclusion Criteria

  • cannot stand for several minutes
  • cannot lie down on a table for 10 minutes
  • over 250 lbs

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Standard 4C fat mass compared to simplified 4C model(1-Day)
  • Associations of 3D optical shape and DXA percent body fat.(1 Day)

Study Sites (1)

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