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| Name | Class |
|---|---|
| Seca GmbH & Co. Kg. | INDUSTRY |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| formoline L112 Extra 2 tabletts daily | For weight control (participants with BMI < 25), the dose is reduced to 2 tablets daily |
| |
| formoline L112 Extra 2x2 tabletts daily | For weight reduction (participants with BMI ≥ 25): 2 x 2 tablets with the two meals with the highest fat content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| formoline L112 EXTRA | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (Body-Mass-Index) | Measurement with seca mBCA 555, unit kg/m2 | 12 weeks |
| Body weight | Measurement with seca mBCA 555, unit kg | 12 weeks |
| FMI (Fat-Mass-Index) | Measurement with seca mBCA 555, unit kg/m2 | 12 weeks |
| FM% (fat-mass percentage) | Measurement with seca mBCA 555, unit % | 12 weeks |
| FFMI (fat-free-mass-index) | measured with seca mBCA bioimpedance scale, unit kg/m2 | 12 weeks |
| SSM (Skeletal muscle mass) | measured with seca mBCA bioimpedance scale, unit kg | 12 weeks |
| SMI (Skeletal muscle index) | measured with seca mBCA bioimpedance scale, unit kg/m2 | 12 weeks |
| Skeletal muscle mass depending on age | measured with seca mBCA bioimpedance scale, unit kg | 12 weeks |
| Phase angle |
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Inclusion Criteria:
Exclusion Criteria:
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Aschaffenburg and surrounding area
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Certmedica International GmbH | Aschaffenburg | Bavaria | 63741 | Germany |
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|
measured with seca mBCA bioimpedance scale, unit Degree
| 12 weeks |
| Visceral fat | measured with seca mBCA bioimpedance scale, unit litre | 12 weeks |
| Skeletal muscle mass index of the extremities | measured with seca mBCA bioimpedance scale, unit kg/m2 | 12 weeks |
| Waist circumference | measured manually with meassuring tape, unit cm | 12 weeks |
| Body Composition Chart | produced by seca analytics from seca mBCA bioimpedance measurements of fat mass and skeletal muscle mass. | 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 | 12 weeks |
| TBW (total body water) | measured with seca mBCA bioimpedance scale, unit litre | 12 weeks |
| ECW (extracellular water) | measured with seca mBCA bioimpedance scale, unit litre | 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) | 12 weeks |
| Bioelectrical impedance vector analysis | produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status | 12 weeks |
| TRU Body Score | calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status | 12 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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