Tanita BIA System Validation

NCT02118675 | Completed

• 1 other identifier: PBRC 12021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to collect the body composition data using five different methods-bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical), deuterium dilution (heavy water), body circumferences (tape measure, TC2), and tissue thickness by ultrasound (GE Medical, BodyMetrix).

Conditions

Body Composition; Circumference Measurements; Tissue Thickness Measurements

Outcome Measures

Primary Outcomes (1)

• The Primary purpose is to measure children and adult body composition data using different methods - bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical).

  Tanita® has several Bioelectrical Impedance Analysis (BIA) systems on the market. BIA is considered one of the most reliable and accessible methods of screening body fat. This study will collect data from the Tanita® systems, DXA, BodPod, and total body water to further improve the accuracy of Tanita® products for adults and children.

  One five hour visit (Baseline)

Secondary Outcomes (1)

• The secondary outcome measure it to improve the BIA body composition using deuterium dilution (heavy water), body circumferences (tape measure, TC2, Human Solutions), and tissue thickness by ultrasound (GE Medical, BodyMetrix).

  One five hour visit (Baseline)

Study Arms (2)

Age 5-17 years

Participants age 5 - 17 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) BodPod Circumferences Ultrasound

Other: Body Measurements; Other: Body Composition and Circumference measurements; Other: Whole Body DXA scan; Other: Bioelectrical Impedance Analysis (BIA); Other: BodPod; Other: Circumferences; Other: Ultrasound

Age 18-80 years

Participants age 18-80 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) BodPod Circumferences Ultrasound

Other: Body Measurements; Other: Body Composition and Circumference measurements; Other: Whole Body DXA scan; Other: Bioelectrical Impedance Analysis (BIA); Other: BodPod; Other: Circumferences; Other: Ultrasound

Interventions

Body Measurements OTHER

A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements. Your BMI will be calculated from these measurements.

Age 18-80 years; Age 5-17 years

Body Composition and Circumference measurements OTHER

This test is to measure the amount of water in your body. After a fasting urine sample is collected, you will drink a glass of water that has been enriched with an atom called a stable isotope (deuterium). After you drink this non-radioactive heavy water, you will provide urine samples several times over the next 4 hours.

Also known as: Deuterium Dilution (heavy water)

Age 18-80 years; Age 5-17 years

Whole Body DXA scan OTHER

This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table. You will be carefully positioned on the table, and your legs will be placed together using two Velcro straps. A scanner emitting low energy X-rays and a detector will pass along your body. You will be asked to remain completely still while the scan is in progress. The scan takes approximately ten minutes.

Also known as: DXA scan

Age 18-80 years; Age 5-17 years

Bioelectrical Impedance Analysis (BIA) OTHER

These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will repeat this procedure on three different BIA systems.

Age 18-80 years; Age 5-17 years

BodPod OTHER

This test will estimate the amount of fat mass and fat free mass in your body. You will be required to change into a swimsuit and swim cap that we will provide for this procedure. If your swimsuit meets the necessary criteria, you can bring and wear it for the procedure, or PBRC will provide one for you. You will step onto a scale for a quick weight measurement. Next, you will sit inside of the system like you are sitting in a chair. The door of the system will be closed, but you will have a window so that you can see outside of the system while the measurements are completed. The test will be completed in about 15 minutes.

Age 18-80 years; Age 5-17 years

Circumferences OTHER

This test will measure the circumferences of your waist, hip, neck, arms, and legs and the lengths of your forearm, upper arm, thigh, and lower leg. The circumference measurements will be made by a trained observer using a calibrated tape measure and an automated circumference measurement device (KX-16). These measurements will be made in about 30 minutes.

Also known as: KX-16

Age 18-80 years; Age 5-17 years

Ultrasound OTHER

An ultrasound is a procedure that uses sound waves to create a picture of an organ or soft tissue. This test measures the size of your tissue thicknesses for fat and skeletal muscle. For this procedure, you will be asked to raise your shirt, disrobe from the waist up, or change into a hospital gown and lie flat on your back on an examination table, or sit on a chair, or stand for measuring your leg dimensions. A gel will be spread on the ultrasound probe, and the probe will be applied directly to the skin on your arms, legs, and abdomen. You will feel slight pressure when the probe is applied. The entire procedure will take approximately 30 minutes.

Age 18-80 years; Age 5-17 years

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or Female age 5 - 80 years of age.

You may qualify if:

• Being either male or female
• Being from 5 to 80 years of age
• Being considered normal weight, overweight, or obese based on specified BMI ranges
• Having a bodyweight of less than 440 pounds
• Being willing to comply with the study procedures

You may not qualify if:

• Having metal-containing objects in your body
• Being pregnant or attempting to become pregnant
• Being claustrophobic
• Having medical implants such as a pacemaker or metal joint replacements
• Being a professional athlete or someone with severe oedema or dehydration
• Having a body weight greater than 440 pounds

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Tanita: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Body Weights and Measures; Body Composition; Deuterium Oxide; Absorptiometry, Photon; Waist Circumference; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Metabolism; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Deuterium; Hydrogen; Elements; Gases; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Body Size; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Steven Heymsfield, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 21, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (1)