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 (MEGA L112)

March 24, 2026 updated by: Certmedica International GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63741
        • Certmedica International GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aschaffenburg and surrounding area

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
formoline L112 Extra 2 tabletts daily
For weight control (participants with BMI < 25), the dose is reduced to 2 tablets daily
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (Body-Mass-Index)
Time Frame: 12 weeks
Measurement with seca mBCA 555, unit kg/m2
12 weeks
Body weight
Time Frame: 12 weeks
Measurement with seca mBCA 555, unit kg
12 weeks
FMI (Fat-Mass-Index)
Time Frame: 12 weeks
Measurement with seca mBCA 555, unit kg/m2
12 weeks
FM% (fat-mass percentage)
Time Frame: 12 weeks
Measurement with seca mBCA 555, unit %
12 weeks
FFMI (fat-free-mass-index)
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
12 weeks
SSM (Skeletal muscle mass)
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
12 weeks
SMI (Skeletal muscle index)
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
12 weeks
Skeletal muscle mass depending on age
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
12 weeks
Phase angle
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit Degree
12 weeks
Visceral fat
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
12 weeks
Skeletal muscle mass index of the extremities
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
12 weeks
Waist circumference
Time Frame: 12 weeks
measured manually with meassuring tape, unit cm
12 weeks
Body Composition Chart
Time Frame: 12 weeks
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
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
12 weeks
TBW (total body water)
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
12 weeks
ECW (extracellular water)
Time Frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
12 weeks
Water ratio ECW/TBW
Time Frame: 12 weeks
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
Time Frame: 12 weeks
produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status
12 weeks
TRU Body Score
Time Frame: 12 weeks
calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Certmedica International GmbH

Collaborators

Seca GmbH & Co. Kg.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Actual)

February 26, 2026

Study Completion (Actual)

February 26, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEGA L112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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