InBody Validation Study

Validation Study Clinical Trial

— InBody  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635958
• Other study ID #: 14-004659
• Status: Completed
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2019
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Validation Study

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	BioSpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition Measures	compare body composition measures between InBody and iDXA	1 day

External Links

•   Mayo Clinic Clinical Trials