An observational study in Overweight, sponsored by Certmedica International GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Certmedica International GmbH · Observational
As a combination of medical products (mBCA scale, mBCA standing aid, length measuring rod and cloud-based software), the seca mBCA 555 makes it possible to determine nutritional status, energy consumption and body water distribution. For this purpose, weight, height and bioimpedance data are measured and further body composition parameters are determined. In addition, changes in muscle mass and fat mass resulting from physical training can be assessed. It is a class IIa medical device.
The L112 product range serves as a lipid binder for weight reduction and weight maintenance with an accompanying LDL cholesterol-lowering effect. It is a class III medical device.
The aim of this study is to explore which early changes in body composition and other health parameters accessible by bioimpedance measurement can be detected with the mBCA 555 measurement method when taking the L112 product series even before weight reduction.
If it were possible to detect changes in health parameters that can be recorded with the mBCA 555 at an early stage while taking the L112 product range, a strategy could be developed to motivate users. In the successful treatment of obesity, patient compliance and motivation are crucial due to the necessary dietary and lifestyle changes. Early successes or indications of a good development of the mBCA health parameters, which are visible even before a relevant change in weight, can serve as a motivational aid and lead to better success in weight reduction. This exploratory study aims to identify these parameters as a basis for further clinical studies.
Research question:
What changes in body composition and other health parameters accessible through bioimpedance measurement can be measured when taking the L112 product range before weight loss?
Aschaffenburg and surrounding area
Exclusion Criteria:
For weight control (participants with BMI \< 25), the dose is reduced to 2 tablets daily
Other: formoline L112 EXTRA
For weight reduction (participants with BMI ≥ 25): 2 x 2 tablets with the two meals with the highest fat content
Other: formoline L112 EXTRA
Taking formoline L112 EXTRA (750 mg tablets) for a duration of 12 weeks: For weight reduction (participants with BMI ≥ 25): 2 x 2 tablets with the two meals with the highest fat content For weight control (participants with BMI \< 25), the dose is reduced to 2 tablets daily.
BMI (Body-Mass-Index)
Measurement with seca mBCA 555, unit kg/m2
Time frame: 12 weeks
Body weight
Measurement with seca mBCA 555, unit kg
Time frame: 12 weeks
FMI (Fat-Mass-Index)
Measurement with seca mBCA 555, unit kg/m2
Time frame: 12 weeks
FM% (fat-mass percentage)
Measurement with seca mBCA 555, unit %
Time frame: 12 weeks
FFMI (fat-free-mass-index)
measured with seca mBCA bioimpedance scale, unit kg/m2
Time frame: 12 weeks
SSM (Skeletal muscle mass)
measured with seca mBCA bioimpedance scale, unit kg
Time frame: 12 weeks
SMI (Skeletal muscle index)
measured with seca mBCA bioimpedance scale, unit kg/m2
Time frame: 12 weeks
Skeletal muscle mass depending on age
measured with seca mBCA bioimpedance scale, unit kg
Time frame: 12 weeks
Phase angle
measured with seca mBCA bioimpedance scale, unit Degree
Time frame: 12 weeks
Visceral fat
measured with seca mBCA bioimpedance scale, unit litre
Time frame: 12 weeks
Skeletal muscle mass index of the extremities
measured with seca mBCA bioimpedance scale, unit kg/m2
Time frame: 12 weeks
Waist circumference
measured manually with meassuring tape, unit cm
Time frame: 12 weeks
Body Composition Chart
produced by seca analytics from seca mBCA bioimpedance measurements of fat mass and skeletal muscle mass.
Time frame: 12 weeks
Segmental skeletal muscle mass distributed over the 5 segments: Arm right, Arm left, torso, leg right, leg left
measured with seca mBCA bioimpedance scale, unit kg
Time frame: 12 weeks
TBW (total body water)
measured with seca mBCA bioimpedance scale, unit litre
Time frame: 12 weeks
ECW (extracellular water)
measured with seca mBCA bioimpedance scale, unit litre
Time frame: 12 weeks
Water ratio ECW/TBW
calculated by seca analytics from measured with seca mBCA bioimpedance scale of ECW (extracellular water) and TBW (total body water)
Time frame: 12 weeks
Bioelectrical impedance vector analysis
produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status
Time frame: 12 weeks
TRU Body Score
calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status
Time frame: 12 weeks
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH