Recruiting

Body Composition Evaluation

Sponsor:

NIH

Code:

NCT07776678

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Obesity & Overweight

Study ID

NCT07776678

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Modality-reference agreement for total fat mass (kg) [ Time Frame: 4 Weeks ]
  • Modality-reference agreement for fat-free mass (kg) [ Time Frame: 4 Weeks ]
  • Modality-reference agreement for percent body fat (%) [ Time Frame: 4 Weeks ]
  • Modality-reference agreement for visceral adipose tissue (VAT; kg or volume) [ Time Frame: 4 Weeks ]

Central Contacts and Locations

Central contacts

Steven Heymsfield, MD

650-688-4070bodycompstudy@exponent.com

Ariel Dowling, PhD

650-688-4070bodycompstudy@exponent.com

Locations

Exponent Phoenix

Recruiting

Phoenix, Arizona, United States, 85027

Contacts

Marysol Luna

650-688-4070bodycompstudy@exponent.com

Exponent Boston

Recruiting

Boston, Massachusetts, United States, 01760

Contacts

Ariel Dowling

650-688-4070bodycompstudy@exponent.com

More Information

Sponsor

Foundation for the National Institutes of Health

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Body Composition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Foundation for the National Institutes of Health on 2026-08-20.