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OpenTrials
Completed

NCT Number: NCT02635958

InBody Validation Study

With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

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Key information

Conditions

Validation Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 65 years of age
  • Have a Body Mass Index ≥ 18.5 kg/m2

Exclusion criteria

  • Are not English speaking
  • Are younger than 18 years of age
  • Weigh more than 450 lbs
  • Taller than 6'6" due to size constraints of the iDXA
  • Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
  • People having radioactive iodine thyroid treatment.
  • People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
  • People with large amounts of metal in their bodies.
  • People with arthritis of the spine recorded in the medical record.
  • Are pregnant

Treatment and study plan

Primary outcomes

  1. Body Composition Measures

    Time frame: 1 day

    compare body composition measures between InBody and iDXA

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • BioSpace, Inc.

Registry information

Official study title

Validation of the InBody 770® for the Assessment of Body Composition

Acronym: InBody

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Dec 21, 2015
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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