Body CompositionTanitaNCT02118675
Tanita BIA System Validation
An observational study of Body Composition and Circumference Measurements, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 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, Body Composition and Circumference measurements and Whole Body DXA scan
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 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 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male or Female age 5 - 80 years of age.
Who may be able to join
- 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
Who cannot join
- 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
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: Tanita® BIA System Validation
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).
Read the detailed description
If you are eligible and you choose to participate in this study, you will be asked to come to the Pennington Biomedical Research Center in Baton Rouge between 7:00 and 11:00am after a 10-hour fast (nothing to eat or drink besides water for 10 hours prior to your appointment). The study visit will take approximately five hours. During the visit, you will complete the informed consent process and then complete several body measurements and body composition procedures immediately afterwards.
Description of study procedures
Body Measurements (about 10 minutes):
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.
Body Composition and Circumference Measurements Deuterium Dilution (heavy water) 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.
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. 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.
Bioelectrical Impedance Analysis (BIA) (about 20 minutes):
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.
BodPod (about 30 minutes) 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.
Circumferences (about 30 minutes) 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.
Ultrasound (about 30 minutes) 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.
- Being tested
- Body Measurements, Body Composition and Circumference measurements, Whole Body DXA scan, Bioelectrical Impedance Analysis (BIA), BodPod
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. Your BMI will be calculated from these measurements.
Body Composition and Circumference measurementsOther
Also called Deuterium Dilution (heavy water)
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.
Whole Body DXA scanOther
Also called 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.
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.
BodPodOther
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.
CircumferencesOther
Also called KX-16
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.
UltrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
As part of this analysis additional measurements of body circumferences will be measured with a tape measure and tissue thicknesses by ultrasound will be made.
Measured: One five hour visit (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tanita
- Responsible party
- Principal investigator, Steven Heymsfield, Pennington Biomedical Research Center
- Investigators
- Steven Heymsfield, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118675
- Sponsor's protocol ID
- PBRC 12021
- Acronym
- Tanita
- Status last verified
- May 2017
- First submitted
- 10 Apr 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tanita® BIA System Validation
- ClinicalTrials.gov ID
- NCT02118675
- Acronym / sponsor ID
- Tanita / PBRC 12021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Tanita
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 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 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).
Detailed description
If you are eligible and you choose to participate in this study, you will be asked to come to the Pennington Biomedical Research Center in Baton Rouge between 7:00 and 11:00am after a 10-hour fast (nothing to eat or drink besides water for 10 hours prior to your appointment). The study visit will take approximately five hours. During the visit, you will complete the informed consent process and then complete several body measurements and body composition procedures immediately afterwards.
Description of study procedures
Body Measurements (about 10 minutes):
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.
Body Composition and Circumference Measurements Deuterium Dilution (heavy water) 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.
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. 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.
Bioelectrical Impedance Analysis (BIA) (about 20 minutes):
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.
BodPod (about 30 minutes) 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.
Circumferences (about 30 minutes) 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.
Ultrasound (about 30 minutes) 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 5-17 years | – | Other: Body Measurements, Other: Body Composition and Circumference measurements, Other: Whole Body DXA scan, Other: Bioelectrical Impedance Analysis (BIA), Other: BodPod, Other: Circumferences, Other: UltrasoundParticipants 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 |
| Age 18-80 years | – | Other: Body Measurements, Other: Body Composition and Circumference measurements, Other: Whole Body DXA scan, Other: Bioelectrical Impedance Analysis (BIA), Other: BodPod, Other: Circumferences, Other: UltrasoundParticipants 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 |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or Female age 5 - 80 years of age.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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. Your BMI will be calculated from these measurements. | Other | Age 18-80 years, Age 5-17 years |
| Body Composition and Circumference measurementsAlso: Deuterium Dilution (heavy water)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 | Age 18-80 years, Age 5-17 years |
| Whole Body DXA scanAlso: DXA 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. 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 | Age 18-80 years, Age 5-17 years |
| 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 | Age 18-80 years, Age 5-17 years |
| BodPodThis 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 | Age 18-80 years, Age 5-17 years |
| CircumferencesAlso: KX-16This 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 | Age 18-80 years, Age 5-17 years |
| UltrasoundAn 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. | Other | Age 18-80 years, Age 5-17 years |
Primary outcome
The Primary purpose is to measure children and adult body composition data using different methods - bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical).
Time frame: One five hour visit (Baseline)
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.
1 secondary outcome
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).
Time frame: One five hour visit (Baseline)
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 5 May 2017.
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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.
Steven Heymsfield, MD principal investigator
Pennington Biomedical Research Center
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 5 inclusion and 6 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 5 May 2017. 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?
The Primary purpose is to measure children and adult body composition data using different methods - bioimpedance analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical). (time frame: One five hour visit (Baseline)). 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 5 May 2017.