Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups

Seca

Status: Completed

Conditions: Bioelectrical Impedance Measurement of Healthy Adults

Study type: Observational

Funder types: Industry

Identifiers

NCT01471938

BCA-02

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

• 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

Trial design

130 participants in 4 patient groups

Caucasians

Description:

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

Description:

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

Description:

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

Description:

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.