Ultra Dual-Energy X-ray Absorptiometry (DXA): Accurate and Precise Quantitative Multi-compartment Body Composition

NCT03430323 | Completed DMC

• 1 other identifier: P0515173
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Composition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 Day

Secondary Outcomes (2)

• Associations of 3D optical shape and DXA percent body fat.

  1 Day

• Standard 4C fat mass compared to simplified 4C model

  1-Day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Hologic, Inc.: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Study Officials

• John A Shepherd, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 12, 2018
• Study Start: August 29, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

US (1)