Shifting paradigms in metabolic health: preparing a monacolin k-free, multi-target era

The European regulatory framework for dietary supplements is undergoing a significant transition. For several years, monacolins from red yeast rice — historically among the most widely used natural ingredients for cholesterol management — have been under close safety scrutiny by the European Food Safety Authority (EFSA). Following EFSA’s scientific assessments, the European Commission initiated a formal procedure to restrict these substances. Recently, this process reached a pivotal milestone with a positive vote by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). With a majority of Member States voting in favor of the restriction, the market is now preparing for a definitive ban on monacolins in the coming months.

Rather than representing a hurdle, this regulatory shift serves as a catalyst for innovation. The modern nutraceutical industry is rapidly transitioning toward safer, broader, and more comprehensive paradigms of metabolic care.

For years, Indena has anticipated this evolution by developing a robust portfolio of monacolin K-free botanical ingredients. These solutions are meticulously designed, rigorously tested for safety, and clinically proven to support metabolic health not just through a single marker, but through a multi-targeted approach.

The global imperative of metabolic health
Metabolic health is one of the defining wellness challenges of our time. According to the World Health Organization (WHO), non-communicable conditions linked to metabolic imbalances—such as poor cardiovascular wellness, blood sugar fluctuations, and suboptimal lipid profiles—are rising globally, driven by aging populations and lifestyle shifts (WHO Fact Sheets: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).

Furthermore, research published in the Journal of the American College of Cardiology estimates that only a small fraction of the adult population meets optimal cardiometabolic health criteria, highlighting the critical importance of early, proactive lifestyle and dietary interventions (JACC Metabolic Health Study: https://www.jacc.org/doi/10.1016/j.jacc.2022.04.047 ).

Metabolic wellness is inherently interconnected. Addressing cholesterol in isolation is often insufficient; modern nutritional science emphasizes the need to support the body's natural balance across several integrated areas:

- lipid profile and cholesterol optimization;
- healthy blood sugar and insulin sensitivity support;
- management of visceral adipose tissue (abdominal fat) and weight;
- liver and biliary function;
- healthy inflammatory and antioxidant responses.

To address these diverse, interconnected needs, Indena offers four premium, science-backed botanical ingredients for highly effective, monacolin-free solutions.

Indena’s monacolin-free portfolio for metabolic wellness

Vazguard^®: the multi-target bergamot Indena Phytosome^®
Vazguard^® is a standardized Bergamot polyphenolic fraction formulated with Indena Phytosome^® technology. Specifically developed to support comprehensive metabolic balance, it targets visceral fat accumulation, lipid profiles, and healthy glucose metabolism. Clinical evidence demonstrates that Vazguard^® supplementation supports the body’s natural ability to manage abdominal fat, showing a positive modulation of visceral adipose tissue parameters by up to -14.5%. Additionally, research indicates a modulation of LDL-related markers by up to -6.4%, alongside favorable support for insulin sensitivity and liver health markers.

Berbevis^®:  optimized berberine for metabolic balance
Berberine is highly regarded for its positive impact on blood sugar and lipid metabolism, but traditional extracts suffer from poor efficiency and gastrointestinal tolerability. Berbevis^® addresses these challenges by utilizing Indena Phytosome^® technology to optimize health while ensuring excellent tolerability. In clinical evaluations involving subjects with borderline metabolic parameters, Berbevis^® demonstrated significant support for healthy lipid and glucose levels over time. Key observed trends include a modulation of total cholesterol parameters by up to -15%, triglyceride-related markers by up to -29%, and an encouraging HDL modulation of up to +39%.
Know more about Berbevis^® HERE.

Greenselect^® Indena Phytosome^®: enhancing body composition and metabolic rate
Greenselect^® Indena Phytosome^® is a decaffeinated green tea extract and formulated to optimize bioabsorption and benefis. It is widely documented for its supportive role in weight management, healthy body composition, and metabolic balance. Scientific evidence highlights that Greenselect^® Indena Phytosome^® supports metabolic wellness by positively modulating lipid and glycemic markers. Studies show positive modulation of total cholesterol markers up to -25%, triglyceride-related parameters up to -33%, and blood sugar markers up to -10%, complemented by beneficial HDL modulation.
Know more about Greenselect^® Indena Phytosome^® HERE.

Bilear^®: supporting lipids through liver and gut wellness
Bilear® is a standardized artichoke leaf extract (Cynara cardunculus) designed to support natural lipid management by promoting healthy digestion, bile flow, and liver wellness. Scientific research confirms that Bilear^® assists in the optimization of plasma lipid parameters. By supporting the liver's natural metabolic pathways and aiding digestive function, Bilear^® offers a highly complementary mechanism of action within a comprehensive, monacolin K-free metabolic wellness regimen.
Know more about Bilear^® HERE.

The Indena Phytosome^® difference: maximizing botanical potential
Three of the four ingredients in Indena's metabolic portfolio utilize Indena Phytosome^® technology, a proprietary, food-grade delivery system that represents a milestone in nutraceutical science.
Many valuable natural compounds, such as polyphenols and berberine, are inherently hydrophilic (water-soluble) and exhibit poor solubility and low absorption through the lipophilic (fat-soluble) barriers of the human gastrointestinal tract.
The Indena Phytosome^® technology is the original multi-talented technology platform and specifically designed to optimize the bioabsorption and unlock the full potential of selected phytonutrients. Indena Phytosome^® acts by creating a solid dispersion of the actives within a 100% food-grade matrix based on natural lecithin.
This mechanism ensures optimized solubility and bioabsorption, together with enhanced tolerability and safety profile, allowing lower doses of the natural ingredient to achieve superior, scientifically verified efficacy.
Know more about Indena Phytosome^® technology HERE.

The future of metabolic wellness is already here
The upcoming regulatory restrictions on red yeast rice mark the end of an era, but they also open a door to more holistic and complete health strategies. Consumers and brands no longer need to rely on single-target, regulatory-sensitive ingredients to support cardiovascular and metabolic health.
Indena continues to lead the global botanical industry by designing, researching, and manufacturing premium-quality, highly standardized extracts. Backed by rigorous clinical evidence and pioneering delivery systems, Indena offers a broader, multi-target, monacolin K-free vision powered by botanical science and Indena Phytosome^® technology.