Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

NCT01368640 | Completed DMC

• 1 other identifier: BCA-01
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is 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.

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Bioelectrical Impedance of 5 and 50 kHz for one body side

  15 minutes

• Bioelectrical Impedance of 50 kHz for all 4 extremities

  15 minutes

Secondary Outcomes (4)

• 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

  15 minutes

• Generation of prediction equations for Sceletal Muscle Mass based on MRI

  1 hour

• Bioelectrical Impedance in sitting, lying and standing

  15 minutes

• Precision Study

  15 min

Study Arms (1)

healthy adults

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data of 130 healthy adults are planned to be collected.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seca GmbH & Co. Kg.: lead

Study Sites (1)

Institute of Human Nutrition and Food Science

Kiel, 24105, Germany

Location

Related Publications (2)

• Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9.

  PMID: 36933351 DERIVED

• Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.

  PMID: 32977906 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

Study Officials

• Manfred J. Mueller, Prof. Dr. med.

  Christian-Albrechts-University of Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: June 8, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: August 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

DE (1)