Body CompositionSamsungNCT02115425
Calibrate Samsung's BIA to Meseaure Body Composition
An observational study of Body Composition and Circumference Measurements, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Circumference Measurements, Tissue Thickness Measurements
- What is being tested?
- Body Measurements, Whole Body DXA Scan and Bioelectrical Impedance Analysis (BIA)
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male or Female age 10-80 years of age.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Having a body weight greater than 440 pounds
- Being a body builder as judged by the investigator
- Adults unable to consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Samsung Bioimpedance System Calibration Study
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.
Read the 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
- Being tested
- Body Measurements, Whole Body DXA Scan, Bioelectrical Impedance Analysis (BIA), add name here
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body MeasurementsOther
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.
Whole Body DXA ScanOther
Also called Dual-energy X-ray Absorptiometry 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.
Bioelectrical Impedance Analysis (BIA)Other
Also called InBody720, http://www.biospaceamerica.com/Product/ib720.html
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 also hold on to hand electrodes for three other BIA systems.
Bioelectrical Impedance Analysis (BIA)Other
Also called Omron 214, Omron 510, Omron 306
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. You will be asked to hold on to hand electrodes on a hand hold device. You will be asked to complete 3 measurement (less than one minute). You will also hold on to hand electrodes for two other BIA systems.
add name hereOther
| Study group | Role | What they receive |
|---|---|---|
| Age 10-17 | Participants age 5 - 17 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) Receives: Other: Body Measurements; Other: Whole Body DXA Scan; Other: Bioelectrical Impedance Analysis (BIA); Other: add name here | |
| Age 18-80 | 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) Receives: Other: Body Measurements; Other: Whole Body DXA Scan; Other: Bioelectrical Impedance Analysis (BIA); Other: add name here |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment
The study will be conducted in two overlapping phases. In Phase I, approximately 300 adult subjects (>18 to 80 yrs, equal numbers of female and male) will be recruited to take part in this study as detailed below: (1) Underweight (BMI<18.5 k/m2), 50 subjects. (2) Normal-Overweight (18.5-30), 150 subjects. (3) Obese (>30), 100 subjects.
Phase II, planned to start later this spring and summer, will involve evaluation of children and 100 subjects (10-</=18 yrs, equal numbers of female and male) are planned in this phase as: (1) Normal-Overweight (18.5-30), 50 subjects. (2) Obese (>30), 50 subjects. An addendum describing details of this study phase will be forthcoming.
Informed consent for both adults and children will be obtained for this study. Written and verbal assents for children will be obtained for this study.
Measured: First Visit (Only one visit)
Secondary outcomes (1)
Improve the BIA body composition predictions using circumference and tissue thickness measurements
Part II: Verify developed algorithms:
- Task A: Body Fat Analysis
- Task B: Body Muscle Analysis
- Task C: TBW (total body water), ICW (intracellular water), ECW (extracelluar water)
Measured: First Visit (Only one visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung
- Responsible party
- Principal investigator, Jolene Zheng, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115425
- Sponsor's protocol ID
- PBRC 2014-005
- Acronym
- Samsung
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samsung Bioimpedance System Calibration Study
- ClinicalTrials.gov ID
- NCT02115425
- Acronym / sponsor ID
- Samsung / PBRC 2014-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Samsung
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 10-17 | – | Other: Body Measurements, Other: Whole Body DXA Scan, Other: Bioelectrical Impedance Analysis (BIA), Other: add name hereParticipants age 5 - 17 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) |
| Age 18-80 | – | Other: Body Measurements, Other: Whole Body DXA Scan, Other: Bioelectrical Impedance Analysis (BIA), Other: add name hereAge 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) |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or Female age 10-80 years of age.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body MeasurementsA 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. | Other | Age 10-17, Age 18-80 |
| Whole Body DXA ScanAlso: Dual-energy X-ray Absorptiometry ScanThis 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. | Other | Age 10-17, Age 18-80 |
| Bioelectrical Impedance Analysis (BIA)Also: InBody720, http://www.biospaceamerica.com/Product/ib720.htmlThese 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 also hold on to hand electrodes for three other BIA systems. | Other | Age 10-17, Age 18-80 |
| Bioelectrical Impedance Analysis (BIA)Also: Omron 214, Omron 510, Omron 306These 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. You will be asked to hold on to hand electrodes on a hand hold device. You will be asked to complete 3 measurement (less than one minute). You will also hold on to hand electrodes for two other BIA systems. | Other | Age 10-17, Age 18-80 |
| add name here | Other | Age 10-17, Age 18-80 |
Primary outcome
Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment
Time frame: First Visit (Only one visit)
The study will be conducted in two overlapping phases. In Phase I, approximately 300 adult subjects (>18 to 80 yrs, equal numbers of female and male) will be recruited to take part in this study as detailed below: (1) Underweight (BMI<18.5 k/m2), 50 subjects. (2) Normal-Overweight (18.5-30), 150 subjects. (3) Obese (>30), 100 subjects. Phase II, planned to start later this spring and summer, will involve evaluation of children and 100 subjects (10-</=18 yrs, equal numbers of female and male) are planned in this phase as: (1) Normal-Overweight (18.5-30), 50 subjects. (2) Obese (>30), 50 subjects. An addendum describing details of this study phase will be forthcoming. Informed consent for both adults and children will be obtained for this study. Written and verbal assents for children will be obtained for this study.
1 secondary outcome
Improve the BIA body composition predictions using circumference and tissue thickness measurements
Time frame: First Visit (Only one visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Circumference Measurements, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment (time frame: First Visit (Only one visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.