Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFoundation for the National Institutes of Health

About this trial

The purpose of this study is to evaluate body composition across a variety of medical, professional, and commercial devices, including: bioelectrical impedance analysis (BIA) devices, 3-dimensional optical imaging (3DO), manual anthropometry measurements, dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), and blood tests. The secondary study purpose is to compare body composition measurements from BIA devices, 3DO, and manual anthropometry measurements within a 1-week period for a subset of the study population.

The study plans to enroll 300 healthy (having no life-threatening conditions or diseases; male and female) participants, 18 years of age or older.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being willing to provide written informed consent prior to participation Being willing to complete the study visits and comply with the study procedures

Being willing to travel to the various study locations for On-site, DXA, MRI, and Phlebotomy visits

Being willing to change into appropriate form-fitting clothing for 3DO assessments and/or appropriate gowns for DXA and MRI imaging

Must have a BMI within the range of 18.5 - 45 kg/m2

Disqualifiers

Being pregnant or attempting to become pregnant

Having medical implants, such as a pacemaker or metal joint replacements, or other metal implants contraindicated for MRI

Cosmetic implants, such as breast implants

Having a height greater than DXA scanning limit (77 inches)

Trial population

A diverse sample of adults will be recruited for participation in the US. Stratification will occur based on sex and BMI, with additional targets to promote recruitment of a variety of ages and adequate representation of racial and ethnic categories. For race and ethnicity, the goal will be to obtain a distribution approximately equal to the demographics of the United States, with selective oversampling employed as needed. For BMI, the following percentages will be used as approximate goals for the sample (18.50-19.99, None; 20.00-24.99, 20%; 25.00-29.99, 35%; 30.00-34.99, 25%; 35.00-39.99, 13.30%; 40.00-44.99, 6.70%; ≥45, None). However, the distribution of BMI and other demographic characteristics will be monitored as the study progresses in case adjustment is needed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Modality-reference agreement for total fat mass (kg)

Agreement between bioimpedance and 3-dimensional optical imaging derived estimates of total fat mass and DXA-derived reference measurements.

Time frame
4 Weeks
2

Modality-reference agreement for fat-free mass (kg)

Agreement between bioimpedance and 3-dimensional optical imaging derived estimates of fat-free mass and DXA-derived reference measurements.

Time frame
4 Weeks
3

Modality-reference agreement for percent body fat (%)

Agreement between bioimpedance and 3-dimensional optical imaging derived estimates of percent body fat and DXA-derived reference measurements.

Time frame
4 Weeks
4

Modality-reference agreement for visceral adipose tissue (VAT; kg or volume)

Agreement between bioimpedance and 3-dimensional optical imaging derived estimates of visceral adipose tissue and MRI-derived reference measurements.

Time frame
4 Weeks

Secondary outcomes

1

Agreement of blood-based proteomics-derived fat-free mass with DXA-derived fat-free mass (kg)

Agreement between blood-based proteomics-derived fat-free mass and DXA-derived fat-free mass, assessed using the prespecified agreement analyses.

Time frame
4 Weeks
2

Agreement of blood-based proteomics-derived total fat mass with DXA-derived total fat mass (kg)

Description: Agreement between blood-based proteomics-derived total fat mass and DXA-derived total fat mass, assessed using the prespecified agreement analyses.

Time frame
4 Weeks
3

Agreement of blood-based proteomics-derived percent body fat with DXA-derived percent body fat (%)

Agreement between blood-based proteomics-derived percent body fat and DXA-derived percent body fat, assessed using the prespecified agreement analyses.

Time frame
4 Weeks
4

Agreement of blood-based proteomics-derived visceral adipose tissue with MRI-derived visceral adipose tissue

Agreement between blood-based proteomics-derived visceral adipose tissue and MRI-derived visceral adipose tissue, assessed using the prespecified agreement analyses

Time frame
4 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Foundation for the National Institutes of Health

Lead sponsor

Exponent, Inc.

Collaborator

Pennington Biomedical Research Center

Collaborator

Texas Tech University

Collaborator