Study suggests multi-component blend as monacolin alternative amid impending EU ban

Healthy food in heart and cardiograph on blackboard medical abstract concept
The clinical trial evaluated the effects of a proprietary formulation of artichoke, bergamot, berberis, astaxanthin, folic acid and chromium. (Getty Images)

Adults with low to moderate cardiovascular risk who took a monacolin-free combination nutraceutical for 12 weeks improved their lipid profiles, homocysteine levels and metabolic syndrome status, according to a new study published in Nutrients.

The research, funded and supported by Meda Pharma S.p.A., an Italian entity operating under Cooper Consumer Health, evaluated the effects of a proprietary formulation of artichoke, bergamot, berberis, astaxanthin, folic acid and chromium, on markers of cholesterol and heart health.

“Collectively, these findings suggest that nutraceutical formulation (NUT2) may have potential as an adjunct to lifestyle intervention in individuals with low-to-moderate cardiovascular risk whose lipid levels remain suboptimal despite dietary modification,” wrote researchers from Italy, France and the UK.

“These findings are particularly relevant in the context of contemporary European prevention frameworks, which increasingly recognize cardiovascular risk as a continuum and highlight the limitations of lifestyle intervention alone in a substantial proportion of primary prevention patients who do not yet meet criteria for pharmacological therapy,” the report added.

NUT2 contains nutraceuticals that were selected for their established or potential effects on lipid metabolism, homocysteine regulation, oxidative stress and glucose homeostasis. Many previously studied lipid-lowering supplements contain red yeast rice and monacolin K.

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However, earlier this year, the European Commission notified the World Trade Organization of a proposal to prohibit the inclusion of monacolins from red yeast rice in food supplements. This has prompted researchers to explore nutraceutical alternatives for cholesterol management.

Study details

The randomized, double-blind, placebo-controlled, parallel-group study involved 90 adults with low-to-moderate cardiovascular risk and elevated low-density lipoprotein (LDL) cholesterol.

The intervention supplement included a blend of artichoke extract 100 mg, bergamot extract 300 mg (equivalent to flavonoids 120 mg), berberis aristata extract 588 mg, astaxanthin 0.50 mg, folic acid 0.20 mg and chromium 0.04 mg.

They were randomly assigned to receive either one daily tablet of NUT2 or placebo for 12 weeks in addition to standardized dietary advice.

The researchers evaluated markers related to cholesterol, blood glucose, homocysteine, and inflammation, conducted anthropometric measurements, and used statistical analysis to determine differences between groups at 6 and 12 weeks.

The findings showed that at both evaluation time points, the NUT2 supplement group had significant reductions in total cholesterol compared to baseline, while the placebo group showed slight increases.

LDL-C reduced by 9.9% at week 6 and 13.2% at week 12 in the supplement group and increased slightly (+0.6% and +1.6%) in the placebo group.

Although high-density lipoprotein cholesterol (HDL-C) remained higher in the supplement group than in the placebo group, the difference was not statistically significant.

Triglyceride levels were significantly lower at both time points for the NUT2 group.

The researchers also observed that homocysteine concentrations, fasting insulin, and waist circumference were lower in the supplement group than in the placebo group. Additionally, the prevalence of metabolic syndrome “decreased to 13.3% with NUT2, whilst increasing to 37.8% with placebo,” the researchers wrote, while also noting that the supplement was generally well-tolerated with no serious adverse effects.

They acknowledged the study’s limitations, such as its short duration and modest sample size, calling for larger, long-term studies to confirm the role of combination nutraceuticals as adjuncts to lifestyle intervention.


Source: Nutrients 2026, 18(16), 2632; https://doi.org/10.3390/nu18162632, “Effects of a Multi-Component Nutraceutical (NUT2) on the Lipid Profile in Adults with Low-to-Moderate Cardiovascular Risk: A Randomized Placebo-Controlled Trial.”, Authors: V. De Leo et al.