Tanita BIA System Validation

NCT02118675 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2017-05-05

No results posted yet for this study

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

Interventions

OTHER

Body Measurements

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.

OTHER

Body Composition and Circumference measurements

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.

OTHER

Whole Body DXA scan

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.

OTHER

Bioelectrical Impedance Analysis (BIA)

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.

OTHER

BodPod

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.

OTHER

Circumferences

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.

OTHER

Ultrasound

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.

Sponsors & Collaborators

  • Tanita

    collaborator UNKNOWN
  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Steven Heymsfield, MD · Pennington Biomedical Research Center

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118675 on ClinicalTrials.gov