OverweightMEGA L112NCT07495696
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
An observational study of Overweight, run by Certmedica International GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- formoline L112 EXTRA
- Type of treatment
- Pill or oral medicine
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2025to 26 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aschaffenburg and surrounding area
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- formoline L112 EXTRA
- Keywords
- formoline L112, Bioimpedance scale, Overweight, Body composition
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formoline L112 EXTRAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| formoline L112 Extra 2 tabletts daily | For weight control (participants with BMI < 25), the dose is reduced to 2 tablets daily Receives: Other: formoline L112 EXTRA | |
| 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 Receives: Other: formoline L112 EXTRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (Body-Mass-Index)
Measurement with seca mBCA 555, unit kg/m2
Measured: 12 weeks
Body weight
Measurement with seca mBCA 555, unit kg
Measured: 12 weeks
FMI (Fat-Mass-Index)
Measurement with seca mBCA 555, unit kg/m2
Measured: 12 weeks
FM% (fat-mass percentage)
Measurement with seca mBCA 555, unit %
Measured: 12 weeks
FFMI (fat-free-mass-index)
measured with seca mBCA bioimpedance scale, unit kg/m2
Measured: 12 weeks
SSM (Skeletal muscle mass)
measured with seca mBCA bioimpedance scale, unit kg
Measured: 12 weeks
SMI (Skeletal muscle index)
measured with seca mBCA bioimpedance scale, unit kg/m2
Measured: 12 weeks
Skeletal muscle mass depending on age
measured with seca mBCA bioimpedance scale, unit kg
Measured: 12 weeks
Phase angle
measured with seca mBCA bioimpedance scale, unit Degree
Measured: 12 weeks
Visceral fat
measured with seca mBCA bioimpedance scale, unit litre
Measured: 12 weeks
Skeletal muscle mass index of the extremities
measured with seca mBCA bioimpedance scale, unit kg/m2
Measured: 12 weeks
Waist circumference
measured manually with meassuring tape, unit cm
Measured: 12 weeks
Body Composition Chart
produced by seca analytics from seca mBCA bioimpedance measurements of fat mass and skeletal muscle mass.
Measured: 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
Measured: 12 weeks
TBW (total body water)
measured with seca mBCA bioimpedance scale, unit litre
Measured: 12 weeks
ECW (extracellular water)
measured with seca mBCA bioimpedance scale, unit litre
Measured: 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)
Measured: 12 weeks
Bioelectrical impedance vector analysis
produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status
Measured: 12 weeks
TRU Body Score
calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seca GmbH & Co. Kg.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495696
- Sponsor's protocol ID
- MEGA L112
- Acronym
- MEGA L112
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07495696
- Acronym / sponsor ID
- MEGA L112 / MEGA L112
- Conditions
- Overweight
- Keywords
- formoline L112, Bioimpedance scale, Overweight, Body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Seca GmbH & Co. Kg.
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| formoline L112 Extra 2 tabletts daily | – | Other: formoline L112 EXTRAFor weight control (participants with BMI < 25), the dose is reduced to 2 tablets daily |
| formoline L112 Extra 2x2 tabletts daily | – | Other: formoline L112 EXTRAFor weight reduction (participants with BMI ≥ 25): 2 x 2 tablets with the two meals with the highest fat content |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aschaffenburg and surrounding area
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- known allergy to crustaceans or any of the ingredients
- underweight (BMI < 18,5 kg/m²),
- pregnant women
- breastfeeding mothers
- chronic constipation, intestinal obstruction etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| formoline L112 EXTRATaking 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. | Other | formoline L112 Extra 2 tabletts daily, formoline L112 Extra 2x2 tabletts daily |
Primary outcome
BMI (Body-Mass-Index)
Time frame: 12 weeks
Measurement with seca mBCA 555, unit kg/m2
Body weight
Time frame: 12 weeks
Measurement with seca mBCA 555, unit kg
FMI (Fat-Mass-Index)
Time frame: 12 weeks
Measurement with seca mBCA 555, unit kg/m2
FM% (fat-mass percentage)
Time frame: 12 weeks
Measurement with seca mBCA 555, unit %
FFMI (fat-free-mass-index)
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
SSM (Skeletal muscle mass)
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
SMI (Skeletal muscle index)
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
Skeletal muscle mass depending on age
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
Phase angle
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit Degree
Visceral fat
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
Skeletal muscle mass index of the extremities
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg/m2
Waist circumference
Time frame: 12 weeks
measured manually with meassuring tape, unit cm
Body Composition Chart
Time frame: 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
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit kg
TBW (total body water)
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
ECW (extracellular water)
Time frame: 12 weeks
measured with seca mBCA bioimpedance scale, unit litre
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, run by Certmedica International GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (Body-Mass-Index) (time frame: 12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.