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

RecruitingN/A

Sponsor: Foundation for the National Institutes of Health

Conditions: Obesity & Overweight

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* Being willing to refrain from all food, drink, and substances for 8 hours prior to the On-site visit(s) and phlebotomy visit
* Being willing to refrain from all food, drink, and substances for 4 hours prior to the DXA and MRI scan visits
* Being willing to refrain from any exercise or vigorous physical activity for 24 hours prior to all visits
* Stable weight (no more than 5 kg change) for 3 months prior to screening
* If recruited in the Phoenix, AZ area, participants must be willing to drive yourself to the Phoenix Office location for the On-site Visits 1 and 2 (if applicable) located at the Exponent Phoenix Office.

Exclusion Criteria:

* 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)
* Having a body weight greater than indicated for the equipment (400 lbs)
* Prior amputation or major body-altering surgery that could invalidate body composition estimates
* Having claustrophobia or a history of claustrophobia
* Known HIV infection
* Known Lipodystrophy
* Known hydration abnormality (e.g., significant edema, end-stage renal disease, end-stage liver disease)
* Severe illness or life-threatening conditions such as end-stage kidney, liver, lung disease, NYHA III-IV heart failure, or active malignancy

Locations (3)

Phoenix, Arizona, United States
Menlo Park, California, United States
Boston, Massachusetts, United States