Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Bone Mineral Content (BMC) based on DXA (Dual X-Ray Absorptiometry)
时间窗: about 30 minutes
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.
Bioelectrical Impedance (Resistance and Reactance) of 50 kHz for all 4 extremities
时间窗: about 1 hour
TBW
时间窗: within 4 hours
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).
Bioelectrical Impedance (Resistance and Reactance) of 5 and 50 kHz for one body side
时间窗: about 1 hour
Body Volume based on Air Displacement Plethysmography (ADP)
时间窗: about 30 minutes
Body Volume is used to calculate FFM in addition to DXA, TBW and Body Weight.
ECW
时间窗: within 4 hours
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).
次要结局
- Bioelectrical Impedance (Resistance and Reactance) in sitting, lying and standing body position(about 1 hour)
- 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)