Clinical trial Recruiting at 3 sites Observational Ages 18 and up

Broadening Body Composition Diagnostics for Obesity

Official title: Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity (REAL-BODY)

Run by Foundation for the National Institutes of Health · NCT07776678 · Data updated 2026-11-12

This study tests how different body composition tools compare for people with obesity or overweight, to see which methods give the most accurate picture of fat and lean mass.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorFoundation for the National Institutes of Health
Academic / other
Locations3 sites (Phoenix, Arizona and 2 other locations)
StatusRecruiting
StartedJune 29, 2026
Main results expectedNovember 30, 2026
Study endsMarch 30, 2027
Registry record updatedOctober 26, 2026
Trial IDNCT07776678 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18+ with BMI 18.5–45 kg/m2 who are willing to undergo DXA, MRI, blood tests, and various imaging/anthropometric assessments across multiple sites.

Probably not a fit

Individuals unwilling to travel to multiple sites or undergo imaging like MRI/DXA may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates body composition across multiple devices and methods, including BIA, 3DO, manual measurements, DXA, MRI, and blood tests. A subset will have a side-by-side comparison of BIA, 3DO, and manual measurements within one week. Up to 300 healthy adults aged 18 and older with BMI 18.5–45 kg/m2 will participate at several sites to assess the practicality, agreement, and potential benefits of broadening objective body composition diagnostics. The goal is to improve how obesity and weight-management therapies are monitored beyond total body weight, particularly for treatments aiming to preserve lean mass. The findings could inform future clinical and regulatory use of body composition endpoints.

Why it matters

Potential benefit: If successful, the study could improve how clinicians monitor fat and lean mass during obesity treatment, leading to more precise assessments of treatment effect.

How similar studies have gone: Prior work uses DXA and MRI to quantify body composition, but cost and accessibility limit routine use, so this study extends real-world comparisons across more accessible tools.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Exponent Phoenix
    Phoenix, Arizona, United States
    Recruiting
  • Exponent Menlo Park
    Menlo Park, California, United States
    Recruiting
  • Exponent Boston
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.