Clinical trial NCT02115425: Calibrate Samsung's BIA to Meseaure Body Composition
Official title: Samsung Bioimpedance System Calibration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Circumference Measurements
Tissue Thickness Measurements
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Samsung
First posted: 2014-04-16
Enrollment: 421
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or Female age 10-80 years of age.

Brief summary: The purpose of this study is to collect body composition data using bioimpedance analysis (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5 of this consent. The data collected will help Samsung improve the products the company offers.

Detailed description: If you are eligible and you choose to participate in this study, you will be asked to come to the Bone \& Joint Clinic of Baton Rouge in Baton Rouge between 7:00 and 11:00 am after at least a two-hour fast (nothing to eat or drink besides water for 2 hours prior to your appointment). You will be asked not to exercise, shower, or use a steam room or sauna at least two hours prior to evaluation. The study visit will take approximately one hour. During the visit, you will complete the informed consent process and then complete the baseline body measurements and body composition procedures immediately afterwards. Adult pre-menopausal women will have a urine pregnancy test prior to evaluation. Study procedures are not for diagnostic or treatment purposes and the DXA scan is intended for research purposes.

Description of study procedures

Body Measurements (about 15 minutes):

A series of body measurements will be taken by trained staff. These measurements include height, weight, and vital signs. The weight and height measurements will be completed twice during this time. The subject will wear a hospital gown and tight fitting garments for these procedures and the subject's BMI will be calculated from these measurements.

Body Composition Measurements

Whole Body DXA Scan, about 20 minutes This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. The subject will be required to wear a hospital gown, to remove all metal-containing objects from the body, and to lie down on the table. The subject will be carefully positioned on the table, and the legs will be placed together using two Velcro straps. A scanner emitting low energy X-rays and a detector will pass along the body. The subject will be asked to remain completely still while the scan is in progress. The scan takes approximately ten minutes.

Impedance Analysis (BIA) (about 10 minutes):

These tests will measure the amount of fat in the body. These procedures will vary depending on the measurement system and several different BIA systems will be used during this test.

Some examples are presented in the supplementary material at the end of this protocol.

Specifically, the following systems will be used in this study:

Samsung Health Cover; Measure 3 times; Standing Posture

Marketed systems:

InBody720 (http://www.biospaceamerica.com/Product/ib720.html; measure one time; Standing Posture Omron 306; Measure 1 time; Standing Posture Omron 510; Measure 1 time; Standing Posture

Eligibility criteria: Inclusion Criteria:

* Being either male or female
* Being from 18 to 80 years of age
* Being considered underweight, normal weight, overweight, or obese based on specified BMI ranges
* Having a body weight of less than 440 pounds
* Being willing to comply with the study procedures
* Females must not be pregnant, breastfeeding, or planning to become pregnant within the next 6 months.

Exclusion Criteria:

* Being Asian. Note that Asian subjects have already been evaluated as part of the Korean phase of this investigation.
* Having a significant chronic disease as judged by the investigator
* Having metal-containing objects in your body
* Being pregnant or attempting to become pregnant
* Having medical implants such as a pacemaker or metal joint replacements
* Being a professional athlete or someone with severe edema or dehydration
* Having a body weight greater than 440 pounds
* Being a body builder as judged by the investigator
* Adults unable to consent
* Prisoners

Primary outcomes:
measure: Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment
timeFrame: First Visit (Only one visit)
Secondary outcomes:
measure: Improve the BIA body composition predictions using circumference and tissue thickness measurements
timeFrame: First Visit (Only one visit)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: