NCT07495696

Possibilities of Recording Changes in Various Health Parameters by Measuring Bioimpedance With the mBCA 555 During the Use of Products From the L112 Product Range

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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?

Conditions

• Overweight

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-02-26
• Completion: 2026-02-26
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Germany