Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
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Purpose
The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was 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. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.
| Condition |
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Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA) |
- Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [ Time Frame: about 15 minutes ] [ Designated as safety issue: No ]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.
- Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S. [ Time Frame: about 15 minutes ] [ Designated as safety issue: No ]Predicate Device: BIOSPACE INBODY 720
| Enrollment: | 992 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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healthy adults
The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited.
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Data of 992 healthy adults are planned to be collected.
Inclusion Criteria:
The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".
Exclusion Criteria:
- amputation of limbs
- electrical implant as cardiac pacemaker
- insulin pumps
- probands who cannot provide an ICF by themselves
- probands who might be dependent from the sponsor or the inv. site
- extensive tattoos at arms or legs
Contacts and Locations More Information
No publications provided
| Responsible Party: | Seca GmbH & Co. Kg. |
| ClinicalTrials.gov Identifier: | NCT01481285 History of Changes |
| Other Study ID Numbers: | BCA-03 / BCA-04 |
| Study First Received: | July 21, 2011 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Seca GmbH & Co. Kg.:
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Bioelectrical Impedance Measurement Adults |
ClinicalTrials.gov processed this record on June 18, 2013