Generation of Prediction Equations for BIA of the Elderly
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|ClinicalTrials.gov Identifier: NCT04028648|
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand.
Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Generation of Prediction Equations to Analyze Body Composition of the Elderly Based on Bioelectrical Impedance Analysis (BIA)|
|Actual Study Start Date :||February 4, 2019|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
150 elderlies (>60 years): community dwelling or living in old
- BIA 5 and 50 kHz [ Time Frame: 15 minutes ]Bioelectrical Impedance of 5 and 50 kHz for one body side
- BIA 50 kHz [ Time Frame: 15 minutes ]Bioelectrical Impedance of 50 kHz for all 4 extremities
- Total body water [ Time Frame: 15 minutes ]Total body water (TBW) by deuterium (D2O) dilution
- Extracellular water [ Time Frame: 15 minutes ]Extracellular water (ECW) by NaBr dilution
- Fat-free mass [ Time Frame: 1hour ]Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
- Skeletal muscle mass [ Time Frame: 1 hour ]Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
- Visceral adipose tissue [ Time Frame: 1 hour ]Visceral adipose tissue (VAT) by magnetic resonance imaging MRI
- Complete BIA [ Time Frame: 15 minutes ]Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028648
|Contact: Kristin Klückmann||+4940200000 ext 232||Kristin.Klueckmann@seca.com|
|Institute of Human Nutrition and Food Science||Recruiting|
|Kiel, Germany, 24105|
|Contact: Anja Bosy-Westphal, Prof. Dr. Dr. 0049 431 880 ext 5670 email@example.com|
|Principal Investigator: Anja Bosy-Westphal, Prof. Dr. Dr.|
|Sub-Investigator: Wiebke Braun, Dr.|