InBody Validation Study (InBody)

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

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.

Study Overview

• Status: Completed
• Conditions: Validation Study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group 1; BMI 18.5 to 24.9
Group 2; BMI 25 to 29.9
Group 3; BMI 30 to 34.9
Group 4; BMI ≥ 35

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition Measures	compare body composition measures between InBody and iDXA	1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: BioSpace, Inc.

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (ESTIMATE): December 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Body Mass Index; BMI; validation; InBody; iDXA
• Other Study ID Numbers: 14-004659