Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
1 other identifier
observational
130
1 country
1
Brief 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)". The study bears the code BCA-01.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 9, 2012
February 1, 2012
5 months
July 8, 2011
February 8, 2012
Conditions
Outcome Measures
Primary Outcomes (6)
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
about 1 hour
Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
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.
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.
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).
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).
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
about 1 hour
SMM based on Magnet Resonance Imaging (MRI)
about 1 hour
Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position
about 1 hour
Study Arms (4)
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.
Eligibility Criteria
Data of 130 healthy adults are planned to be collected.
You may qualify if:
- 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.
You may not qualify if:
- acute and chronic diseases
- regular intake of medications (except for contraceptives)
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
- artificial joints
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Body Composition of NY Obesity Research Center
New York, New York, 10025, United States
Related Publications (1)
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;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.
PMID: 32977906DERIVED
Biospecimen
whole blood
Study Officials
- PRINCIPAL INVESTIGATOR
Dympna Gallagher, Dr.
St. Luke's-Roosevelt Hospital Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
November 16, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 9, 2012
Record last verified: 2012-02