Status:
COMPLETED
Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
Lead Sponsor:
Seca GmbH & Co. Kg.
Conditions:
Bioelectrical Impedance Measurement of Healthy Adults
Eligibility:
All Genders
18-65 years
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 "Generati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01471938
Start Date
July 1 2011
End Date
December 1 2011
Last Update
February 9 2012
Active Locations (1)
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1
Body Composition of NY Obesity Research Center
New York, New York, United States, 10025