Improvement of metabolic syndrome with formoline L112

Abstract

Metabolic syndrome (MS) is one of the major risk factors for the development of diabetes mellitus type 2 and cardiovascular disease. Polyglucosamine L112 (formoline L112) is a high-effective-weight fat binder whose efficacy in weight reduction has been demonstrated in a randomized, double-blind, placebo-controlled study (POSO II, 2023) (4). A recent subgroup analysis (2025) investigated its effects in patients with MS (2). After only 3 months, 50% of participants in the verum group achieved remission of MS criteria compared with 25% in the placebo group. Significant improvements were observed in BMI, visceral adipose tissue, fat mass, and insulin resistance. Polyglucosamine L112 therefore provides a non-pharmacological, well-tolerated therapeutic option that goes beyond weight reduction, contributing to a multimodal improvement of cardiometabolic risk profiles.

Introduction

Metabolic syndrome is defined by the coexistence of abdominal obesity, dyslipidemia, hyperglycemia/insulin resistance, and arterial hypertension. It affects up to 25% of adults in Europe (2). Individuals with MS have a substantially increased risk of type 2 diabetes, myocardial infarction, stroke, and non-alcoholic fatty liver disease (NAFLD). Despite clear guideline recommendations, therapy often remains inadequate, as lifestyle interventions alone frequently fail in clinical practice and pharmacological options are limited.

Polyglucosamine L112 (formoline L112) is a medical device that binds dietary fat in the gastrointestinal tract, thereby reducing lipid absorption. Its clinical efficacy in weight reduction has been demonstrated in several trials (5), including the POSO II study published in 2023 with 119 participants, in which weight loss was three times greater compared to placebo (2).

Subgroup Analysis in Patients with Metabolic Syndrome

In 2025, a predefined subgroup of 26 patients with metabolic syndrome from the POSO II trial was separately evaluated (mean age 55 years, BMI 31.1 ± 1.35 kg/m²; 70% female). Patients received either diet + placebo (n = 12) or diet + Polyglucosamine L112 (3 g/day, n = 14) for 90 days.

Key Results:

• Weight & BMI:Significant reductions in the verum group (p < 0.05).
• Visceral adipose tissue (VAT) & fat mass (FM): Marked reductions only in the verum group (p < 0.05).
• Insulin & HOMA index:Significant decrease (p < 0.05; trend for HOMA p = 0.07).
• ATP III clinical criteria:Improvements in waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose – some not statistically significant but clinically relevant.
• MS remission:After 3 months, 50% of verum participants no longer met the criteria for MS compared to only 25% in the placebo group (p < 0.01).

Clinical Relevance

The data demonstrate that Polyglucosamine L112 is more than a weight-loss aid:

Multimodal effect:Reduction of obesity, visceral adiposity, and insulin resistance addresses the core components of MS.

Early intervention:Remission in one out of two patients within 3 months highlights its potential for preventing type 2 diabetes and cardiovascular complications.

Safety:No adverse effects on hepatic or renal function; vitamin levels and glucosamine concentrations remained unchanged; overall excellent tolerability.

Unlike pharmacological options (e.g., GLP-1 receptor agonists, orlistat), Polyglucosamine L112 acts locally in the gut without systemic side effects. It is therefore suitable both as a stand-alone intervention in moderate-risk patients and as an adjunct to pharmacotherapy (e.g., for stabilization after discontinuation of GLP-1 analogues).

Conclusion

Polyglucosamine L112 (formoline L112) offers an innovative, non-pharmacological approach in patients with metabolic syndrome, combining weight reduction with improvements in key cardiometabolic risk factors. Substantial clinical benefits are observed after only a short treatment duration. Thus, the product is well suited for both preventive strategies and as an adjunctive therapeutic tool in high-risk patients.

Sources

(1) Huang PL. A comprehensive definition for metabolic syndrome. Dis Model Mech. 2009 May-Jun;2(5-6):231-7. doi: 10.1242/dmm.001180. PMID: 19407331; PMCID: PMC2675814.

(2) Rondanelli, M., Perna, S., Porta, M.D. et al. Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation. BMC Nutr 11, 170 (2025). https://doi.org/10.1186/s40795-025-01153-8

(3) Cornelli et al.: Long-term treatment of overweight and obesity with polyglucosamine (PG L112): Randomized Study compared with placebo in subjects after caloric restriction. Current developments in nutrition (2017) 1:e000919. DOI: 10.3945/cdn.117.000919

(4) Rondanelli et al.: A Randomized Double-Blind Placebo-Controlled Clinical Study to Evaluate the Effect on the Weight of a Medical Device with Polyglucosamine L112 in a Group of Overweight and Obese Subjects. Nutrients 2023, 15, 3516. https://doi.org/10.3390/nu15163516

(5) Perna, S. et al Effect of Polyglucosamine on Weight Loss and Metabolic Parameters in Overweight and Obesity: A Systematic Review and Meta-Analysis. Nutrients 2020, 12, 2365; doi:10.3390/nu12082365

About formoline L112

formoline L112 is an over-the-counter medicinal product in tablet form whose efficacy and safety have been clinically tested. It is also the first of its kind to be approved under the new European legislation (EU) 2017/745 (MDR). It contains the active ingredient polyglucosamine L112, a dietary fiber that binds significant amounts of dietary fat, thereby reducing its absorption from the intestine. It can also bind oxidized fats and cholesterol. Formoline L112 thus supports weight reduction and control and has the side effect of lowering LDL cholesterol. In a one-year study, adding formoline L112 to two daily meals led to more significant weight loss than lifestyle changes alone. On average, participants who took formoline L112 lost 12 kilograms over the course of the year (3). Clinical studies also show positive effects and improvements in systemic inflammation (hsCRP), insulin levels, insulin resistance, and blood pressure. Certmedica continuously invests in clinical studies to expand the medical application of the formoline product range and appeal to new patient groups.

About Certmedica International

Certmedica International GmbH is a private healthcare company based in Aschaffenburg in the greater Frankfurt am Main area, Germany, since 2005. It strives to become a global leader in the medical fields of overweight and obesity, as well as related diseases and metabolic syndrome. As such, the company develops, manufactures, and distributes medical devices, dietary supplements, and cosmetics that comply with ISO 13485 and Regulation (EU) 2017/745 (MDR), among other standards. In addition, Certmedica acts as a pharmaceutical wholesaler in accordance with §52a AMG (German Medicines Act) with medicinal products. Today, Certmedica operates successfully in over.

40 countries worldwide through its own pharmacy distribution network in Germany and Austria and its international distribution network. With its strong own brands formoline® and aldiamed®, Certmedica is the number one OTC product for obesity in its home market and has other high-quality products in its portfolio whose effectiveness and benefits have been proven in clinical studies.

Contact:

Certmedica International GmbH
Magnolienweg 17
63741 Aschaffenburg
Germany

+49 6021 15093 0
PR@certmedica.de
www.certmedica.de // www.L112.com