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

Sponsored by Foundation for the National Institutes of Health

About this study

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.

Obesity is a disease of excess and abnormal distribution of adipose tissue. Even though negative metabolic outcomes of obesity are driven by adipose tissue, investigators still use body weight (comprised of both fat and fat-free mass) in the calculation of body mass index (weight in kg divided by height in meters squared) to define, subclassify and monitor treatment in people with obesity. Despite this traditional focus on body weight, body composition is an important consideration in the management of people with obesity. Clinical trials and clinical research often use DXA and MRI to quantify changes in body composition; however these methods are expensive and not easily implemented. It is desirable to monitor fat mass and other body composition outcomes in individuals with obesity takin…

Where this study is enrolling (2)

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.