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Completed

NCT Number: 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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Certmedica International GmbH

Aschaffenburg, Bavaria, 63741, Germany

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

formoline L112 EXTRA

Other

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.

Primary outcomes

  1. BMI (Body-Mass-Index)

    Time frame: 12 weeks

    Measurement with seca mBCA 555, unit kg/m2

  2. Body weight

    Time frame: 12 weeks

    Measurement with seca mBCA 555, unit kg

  3. FMI (Fat-Mass-Index)

    Time frame: 12 weeks

    Measurement with seca mBCA 555, unit kg/m2

  4. FM% (fat-mass percentage)

    Time frame: 12 weeks

    Measurement with seca mBCA 555, unit %

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

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit kg/m2

  6. SSM (Skeletal muscle mass)

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit kg

  7. SMI (Skeletal muscle index)

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit kg/m2

  8. Skeletal muscle mass depending on age

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit kg

  9. Phase angle

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit Degree

  10. Visceral fat

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit litre

  11. Skeletal muscle mass index of the extremities

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit kg/m2

  12. Waist circumference

    Time frame: 12 weeks

    measured manually with meassuring tape, unit cm

  13. Body Composition Chart

    Time frame: 12 weeks

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

  14. 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

  15. TBW (total body water)

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit litre

  16. ECW (extracellular water)

    Time frame: 12 weeks

    measured with seca mBCA bioimpedance scale, unit litre

  17. 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)

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Collaborators

  • Seca GmbH & Co. Kg.

Registry information

Acronym: MEGA L112

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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