Recruiting nowNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot listed
ConditionObesity & Overweight
Full registry 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
Primary outcomes
Modality-reference agreement for total fat mass (kg)4 WeeksAgreement between bioimpedance and 3-dimensional optical imaging derived estimates of total fat mass and DXA-derived reference measurements.
Modality-reference agreement for fat-free mass (kg)4 WeeksAgreement between bioimpedance and 3-dimensional optical imaging derived estimates of fat-free mass and DXA-derived reference measurements.
Modality-reference agreement for percent body fat (%)4 WeeksAgreement between bioimpedance and 3-dimensional optical imaging derived estimates of percent body fat and DXA-derived reference measurements.
Modality-reference agreement for visceral adipose tissue (VAT; kg or volume)4 WeeksAgreement between bioimpedance and 3-dimensional optical imaging derived estimates of visceral adipose tissue and MRI-derived reference measurements.
