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

NCT07495696 | Completed

• 1 other identifier: MEGA L112
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight

Keywords

formoline L112; Bioimpedance scale; Overweight; Body composition

Outcome Measures

Primary Outcomes (19)

• BMI (Body-Mass-Index)

  Measurement with seca mBCA 555, unit kg/m2

  12 weeks

• Body weight

  Measurement with seca mBCA 555, unit kg

  12 weeks

• FMI (Fat-Mass-Index)

  Measurement with seca mBCA 555, unit kg/m2

  12 weeks

• FM% (fat-mass percentage)

  Measurement with seca mBCA 555, unit %

  12 weeks

• FFMI (fat-free-mass-index)

  measured with seca mBCA bioimpedance scale, unit kg/m2

  12 weeks

• SSM (Skeletal muscle mass)

  measured with seca mBCA bioimpedance scale, unit kg

  12 weeks

• SMI (Skeletal muscle index)

  measured with seca mBCA bioimpedance scale, unit kg/m2

  12 weeks

• Skeletal muscle mass depending on age

  measured with seca mBCA bioimpedance scale, unit kg

  12 weeks

• Phase angle

  measured with seca mBCA bioimpedance scale, unit Degree

  12 weeks

• Visceral fat

  measured with seca mBCA bioimpedance scale, unit litre

  12 weeks

• Skeletal muscle mass index of the extremities

  measured with seca mBCA bioimpedance scale, unit kg/m2

  12 weeks

• Waist circumference

  measured manually with meassuring tape, unit cm

  12 weeks

• Body Composition Chart

  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

  measured with seca mBCA bioimpedance scale, unit kg

  12 weeks

• TBW (total body water)

  measured with seca mBCA bioimpedance scale, unit litre

  12 weeks

• ECW (extracellular water)

  measured with seca mBCA bioimpedance scale, unit litre

  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)

  12 weeks

• Bioelectrical impedance vector analysis

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

  12 weeks

• TRU Body Score

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

  12 weeks

Study Arms (2)

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

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.

formoline L112 Extra 2 tabletts daily; formoline L112 Extra 2x2 tabletts daily

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aschaffenburg and surrounding area

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seca GmbH & Co. Kg.: collaborator
• Certmedica International GmbH: lead

Study Sites (1)

Certmedica International GmbH

Aschaffenburg, Bavaria, 63741, Germany

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2025
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

DE (1)