Bioelectrical Impedance Measurement of Healthy AdultsNCT03779932
Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA
An observational study of Bioelectrical Impedance Measurement of Healthy Adults, run by Seca GmbH & Co. Kg. at 1 site in Germany.
Trial summary
The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bioelectrical Impedance Measurement of Healthy Adults
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2015to 24 Feb 2016
- 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
- Adult, Older adult
Study population: 38 healthy obese adults
Who may be able to join
- healthy adults in an
- age range of 18 to 65 years
- BMI > 30 kg/m2
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 14Show 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
- extensive tattoos at arms or legs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)
The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.
What is being measured
The primary outcome is the main question the study is designed to answer.
BIA 5 and 50 kHz
Bioelectrical Impedance of 5 and 50 kHz for one body side
Measured: 15 minutes
BIA 50 kHz
Bioelectrical Impedance of 50 kHz for all 4 extremities
Measured: 15 minutes
Total body water
Total body water (TBW) by deuterium (D2O) dilution
Measured: 15 minutes
Extracellular water
Extracellular water (ECW) by NaBr dilution
Measured: 15 minutes
Fat-free mass
Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
Measured: 1 hour
Skeletal muscle mass
Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
Measured: 1 hour
Visceral adipose tissue
Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
Measured: 1 hour
Secondary outcomes (1)
Complete BIA
Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start23 Feb 2015
- Primary completion24 Feb 2016
- Study completion24 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seca GmbH & Co. Kg.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manfred J Müller, Prof. Dr., Principal investigator, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779932
- Sponsor's protocol ID
- BCA-20
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9.
PubMed 36933351Jensen 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)
- ClinicalTrials.gov ID
- NCT03779932
- Acronym / sponsor ID
- BCA-20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seca GmbH & Co. Kg.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2015 (actual)
- Primary completion
- 24 Feb 2016 (actual)
- Study completion
- 24 Feb 2016 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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 was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 38 healthy obese adults
Key inclusion criteria (3 listed)
- healthy adults in an
- age range of 18 to 65 years
- BMI > 30 kg/m2
Key exclusion criteria (14 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
BIA 5 and 50 kHz
Time frame: 15 minutes
Bioelectrical Impedance of 5 and 50 kHz for one body side
BIA 50 kHz
Time frame: 15 minutes
Bioelectrical Impedance of 50 kHz for all 4 extremities
Total body water
Time frame: 15 minutes
Total body water (TBW) by deuterium (D2O) dilution
Extracellular water
Time frame: 15 minutes
Extracellular water (ECW) by NaBr dilution
Fat-free mass
Time frame: 1 hour
Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
Skeletal muscle mass
Time frame: 1 hour
Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
Visceral adipose tissue
Time frame: 1 hour
Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
1 secondary outcome
Complete BIA
Time frame: 15 minutes
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 24 Jul 2019.
- Derived from this study: PubMed 36933351Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9.
- 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.
- Individual participant dataSharing planned: No
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.
Manfred J Müller, Prof. Dr. principal investigator
University of Kiel
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 Germany.
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 3 inclusion and 14 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 24 Jul 2019. 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 Germany. 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?
BIA 5 and 50 kHz (time frame: 15 minutes). The study lists 7 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 NCT03779932, which also lists 2 linked publications.
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 24 Jul 2019.