NCT07776678 · Foundation for the National Institutes of Health
Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity
(REAL-BODY)
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.
View original scientific description
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.
Primary outcome measures
Modality-reference agreement for total fat mass (kg)
Time frame: 4 Weeks
Agreement 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)
Time frame: 4 Weeks
Agreement 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 (%)
Time frame: 4 Weeks
Agreement 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)
Time frame: 4 Weeks
Agreement between bioimpedance and 3-dimensional optical imaging derived estimates of visceral adipose tissue and MRI-derived reference measurements.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Phoenix, Arizona
- Menlo Park, California
- Boston, Massachusetts
Collaborators
Exponent, Inc., Pennington Biomedical Research Center, Texas Tech University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations