Bioelectrical Impedance Measurement of Healthy AdultsNCT01471938
Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
An observational study of Bioelectrical Impedance Measurement of Healthy Adults, run by Seca GmbH & Co. Kg. at 1 site in United States.
Trial summary
The aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioelectrical Impedance Measurement of Healthy Adults
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data of 130 healthy adults are planned to be collected.
Who may be able to join
- The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
Who cannot join
- acute and chronic diseases
- regular intake of medications (except for contraceptives)
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
- artificial joints
Show all 15Show fewer
- metallic implants (except tooth implants)
- claustrophobia
- pregnancy or breastfeeding period
- probands who cannot provide an ICF by themselves
- probands who might be dependent from the sponsor or the inv. site
- current alcohol abuse
- frequent hypersensitivity reactions/allergies determ. anamnestically
- body weight of more than 150 kg
- extensive tattoos at arms or legs
Trial locations and contacts
1 site in 1 country.
United States1 site
Body Composition of NY Obesity Research Center
New York, New York, 10025
About this study
The aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caucasians | 31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. | |
| Afro Americans | 31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. | |
| East and Southeast Asian | 31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. | |
| Hispanics | 31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
Measured: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
Measured: about 1 hour
Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
BMC is used to calculate Fat Free Mass (FFM). In addition to that Body Volume, Total Body Water (TBW) and Body Weight is needed. DXA is used as reference measurement for Skeletal Muscle Mass (SMM) as well.
Measured: about 30 minutes
Body Volume based on Air Displacement Plethysmography (ADP)
Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.
Measured: about 30 minutes
TBW
A D2O dose of 400 mg per kg body weight mixed with tap water is administered orally in the morning fasting and after a 2 hour fluid abstention. The distribution of the stable isotope in the TBW is completed after 4 hours. During this period, the subject remains fasting. Two venous blood samples of 10 ml whole blood are taken immediately before and four hours after taking D2O. The plasma samples are analyzed using Isoptopic Ratio Mass Spectrometry (IRMS).
Measured: within 4 hours
ECW
Orally administered NaBr is resorbed quickly and completely and almost exclusively distributes in the extracellular compartment. Blood samples of 10 ml are taken immediately before and 4 hours after oral application of 50 mg NaBr per kg body weight. The serum sample is analyzed by X-Ray Fluorescence Spectroscopy (XRF).
Measured: within 4 hours
Secondary outcomes (3)
Bioelectrical Impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are planned to be measured.
Measured: about 1 hour
SMM based on Magnet Resonance Imaging (MRI)
Measured: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position
Measured: about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioelectrical Impedance Measurement of Healthy AdultsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seca GmbH & Co. Kg.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dympna Gallagher, Dr., Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471938
- Sponsor's protocol ID
- BCA-02
- Status last verified
- Feb 2012
- First submitted
- 8 Jul 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84(1):10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.
PubMed 32977906
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
- ClinicalTrials.gov ID
- NCT01471938
- Acronym / sponsor ID
- BCA-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seca GmbH & Co. Kg.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Nov 2011 (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 aim of the study is to apply and adapt device specific body composition formulas to various ethnic groups. Bases are prediction equations that are generated in the clinical investigation "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caucasians | – | –31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. |
| Afro Americans | – | –31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. |
| East and Southeast Asian | – | –31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. |
| Hispanics | – | –31 healthy adults in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data of 130 healthy adults are planned to be collected.
Key inclusion criteria (1 listed)
- The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.
Key exclusion criteria (15 listed)
- acute and chronic diseases
- regular intake of medications (except for contraceptives)
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
Time frame: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
Time frame: about 1 hour
Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
Time frame: about 30 minutes
BMC is used to calculate Fat Free Mass (FFM). In addition to that Body Volume, Total Body Water (TBW) and Body Weight is needed. DXA is used as reference measurement for Skeletal Muscle Mass (SMM) as well.
Body Volume based on Air Displacement Plethysmography (ADP)
Time frame: about 30 minutes
Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.
TBW
Time frame: within 4 hours
A D2O dose of 400 mg per kg body weight mixed with tap water is administered orally in the morning fasting and after a 2 hour fluid abstention. The distribution of the stable isotope in the TBW is completed after 4 hours. During this period, the subject remains fasting. Two venous blood samples of 10 ml whole blood are taken immediately before and four hours after taking D2O. The plasma samples are analyzed using Isoptopic Ratio Mass Spectrometry (IRMS).
ECW
Time frame: within 4 hours
Orally administered NaBr is resorbed quickly and completely and almost exclusively distributes in the extracellular compartment. Blood samples of 10 ml are taken immediately before and 4 hours after oral application of 50 mg NaBr per kg body weight. The serum sample is analyzed by X-Ray Fluorescence Spectroscopy (XRF).
3 secondary outcomes
Bioelectrical Impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
Time frame: about 1 hour
SMM based on Magnet Resonance Imaging (MRI)
Time frame: about 1 hour
Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position
Time frame: about 1 hour
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 9 Feb 2012.
- Derived from this study: PubMed 32977906Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84(1):10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.
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.
Dympna Gallagher, Dr. principal investigator
St. Luke's-Roosevelt Hospital 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 Bioelectrical Impedance Measurement of Healthy Adults, run by Seca GmbH & Co. Kg. 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 1 inclusion and 15 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 9 Feb 2012. 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?
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side (time frame: about 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471938, which also lists 1 linked publication.
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 9 Feb 2012.