Overweight
Conditions
Keywords
formoline L112, Bioimpedance scale, Overweight, Body composition
Brief summary
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.
Detailed description
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?
Interventions
OTHERformoline 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.
Sponsors
Certmedica International GmbH
Seca GmbH & Co. Kg.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Declaration of consent * Privacy policy * Adults \> 18 years of age (women and men) * Nutritional profile: High-fat diet / mixed-fat diet * Contraception for participants who could become pregnant
Exclusion criteria
* known allergy to crustaceans or any of the ingredients * underweight (BMI \< 18,5 kg/m²), * pregnant women * breastfeeding mothers * chronic constipation, intestinal obstruction etc. * serious gastrointestinal diseases and condition after operations on the gastrointestinal tract * Long-term use of medication with the exception of contraceptives * Intake of formoline L112, formoline L112 EXTRA, Sterolsan, Liporeform protect, Liposlim nutritabs in the last 4 weeks * Monaten If taken for weight reduction: Weight reduction measure in the last 3 months * Pronounced fluctuations in body weight in the last 3 months * Electrical implants such as pacemakers * Active prostheses * Use of portable electronic medical devices such as infusion pumps or ECG devices * People with cardiac arrhythmia * Acute illnesses * Chronic diseases other than controlled diabetes mellitus * Amputated limbs * Artificial joints * Metal implants with the exception of teeth * Alcohol abuse * Continuous intake of formoline L112 in the last 4 weeks before the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI (Body-Mass-Index) | 12 weeks | Measurement with seca mBCA 555, unit kg/m2 |
| Body weight | 12 weeks | Measurement with seca mBCA 555, unit kg |
| FMI (Fat-Mass-Index) | 12 weeks | Measurement with seca mBCA 555, unit kg/m2 |
| FM% (fat-mass percentage) | 12 weeks | Measurement with seca mBCA 555, unit % |
| FFMI (fat-free-mass-index) | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg/m2 |
| SSM (Skeletal muscle mass) | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg |
| SMI (Skeletal muscle index) | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg/m2 |
| Skeletal muscle mass depending on age | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg |
| Phase angle | 12 weeks | measured with seca mBCA bioimpedance scale, unit Degree |
| Visceral fat | 12 weeks | measured with seca mBCA bioimpedance scale, unit litre |
| Skeletal muscle mass index of the extremities | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg/m2 |
| Waist circumference | 12 weeks | measured manually with meassuring tape, unit cm |
| Body Composition Chart | 12 weeks | produced by seca analytics from seca mBCA bioimpedance measurements of fat mass and skeletal muscle mass. |
| Segmental skeletal muscle mass distributed over the 5 segments: Arm right, Arm left, torso, leg right, leg left | 12 weeks | measured with seca mBCA bioimpedance scale, unit kg |
| TBW (total body water) | 12 weeks | measured with seca mBCA bioimpedance scale, unit litre |
| ECW (extracellular water) | 12 weeks | measured with seca mBCA bioimpedance scale, unit litre |
| Water ratio ECW/TBW | 12 weeks | calculated by seca analytics from measured with seca mBCA bioimpedance scale of ECW (extracellular water) and TBW (total body water) |
| Bioelectrical impedance vector analysis | 12 weeks | produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status |
| TRU Body Score | 12 weeks | calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status |
Countries
Germany
Outcome results
None listed