ClinicalTrials.gg
CompletedNCT07495696MEGA L112Updated Mar 27, 2026

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 in Overweight, sponsored by Certmedica International GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Certmedica International GmbH · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
41
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 149 studies in Overweight with a site in Germany — 38 open to participants now, 60 under way, 34 of them phase 3. Overweight · Germany.

Started
2025
with 24 others
Observational
8 of 149
1 open now
Registered
128th of 149
by date
Lead sponsor
3 of 149
Certmedica International GmbH

Among the 149 studies in Overweight with a site in Germany, this one is one of 25 that started in 2025, is one of 8 observational ones, and was the 128th registered.

Overweight

3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.

Browse Overweight studies →

Open to participants now

38 of the 149 studies in Overweight with a site in Germany are open now. Recruiting first, the newest first:

33 more — sign in →

All 38 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 529 Overweight studies recruiting now, 158 (30%) set no upper age limit and 343 (65%) stop at 75 or younger; 62 take children under 18; 204 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study 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.

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?

03

Conditions studied

  • Overweight

Browse trials for

Keywords

  • formoline L112
  • Bioimpedance scale
  • Overweight
  • Body composition
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Aschaffenburg and surrounding area

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Declaration of consent
  • Privacy policy
  • Adults > 18 years of age (women and men)
  • Nutritional profile: High-fat diet / mixed-fat diet
  • for participants who could become pregnant

Exclusion criteria

Exclusion Criteria:

  • known allergy to crustaceans or any of the ingredients
  • underweight ( \< 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
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. BMI (Body-Mass-Index)

    Measurement with seca mBCA 555, unit kg/m2

    Time frame: 12 weeks

  2. Body weight

    Measurement with seca mBCA 555, unit kg

    Time frame: 12 weeks

  3. FMI (Fat-Mass-Index)

    Measurement with seca mBCA 555, unit kg/m2

    Time frame: 12 weeks

  4. FM% (fat-mass percentage)

    Measurement with seca mBCA 555, unit %

    Time frame: 12 weeks

  5. FFMI (fat-free-mass-index)

    measured with seca mBCA bioimpedance scale, unit kg/m2

    Time frame: 12 weeks

  6. SSM (Skeletal muscle mass)

    measured with seca mBCA bioimpedance scale, unit kg

    Time frame: 12 weeks

  7. SMI (Skeletal muscle index)

    measured with seca mBCA bioimpedance scale, unit kg/m2

    Time frame: 12 weeks

  8. Skeletal muscle mass depending on age

    measured with seca mBCA bioimpedance scale, unit kg

    Time frame: 12 weeks

  9. Phase angle

    measured with seca mBCA bioimpedance scale, unit Degree

    Time frame: 12 weeks

  10. Visceral fat

    measured with seca mBCA bioimpedance scale, unit litre

    Time frame: 12 weeks

  11. Skeletal muscle mass index of the extremities

    measured with seca mBCA bioimpedance scale, unit kg/m2

    Time frame: 12 weeks

  12. Waist circumference

    measured manually with meassuring tape, unit cm

    Time frame: 12 weeks

  13. Body Composition Chart

    produced by seca analytics from seca mBCA bioimpedance measurements of fat mass and skeletal muscle mass.

    Time frame: 12 weeks

  14. 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

    Time frame: 12 weeks

  15. TBW (total body water)

    measured with seca mBCA bioimpedance scale, unit litre

    Time frame: 12 weeks

  16. ECW (extracellular water)

    measured with seca mBCA bioimpedance scale, unit litre

    Time frame: 12 weeks

  17. Water ratio ECW/TBW

    calculated by seca analytics from measured with seca mBCA bioimpedance scale of ECW (extracellular water) and TBW (total body water)

    Time frame: 12 weeks

  18. Bioelectrical impedance vector analysis

    produced by seca analytics from seca mBCA bioimpedance scale measurements concerning body cell mass and hydration status

    Time frame: 12 weeks

  19. TRU Body Score

    calculated by seca analytics from seca mBCA bioimpedance scale measurements of muscle and fat mass, reflecting training status

    Time frame: 12 weeks

07

Study locations

1 site
  • Certmedica International GmbH
    Aschaffenburg, Bavaria 63741, Germany
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Feb 2026, 10 months.

Of 169 observational studies under Overweight, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 91. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2026
First posted
Mar 27, 2026
StartActual
Apr 15, 2025
Primary completionActual
Feb 26, 2026
CompletionActual
Feb 26, 2026
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07495696
Lead sponsor
Certmedica International GmbH
Collaborators
Seca GmbH & Co. Kg.
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Apr 15, 2025
Primary completion
Feb 26, 2026
Completion
Feb 26, 2026
Last update
Mar 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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