Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study

Arrigo F G Cicero, Giuseppe Derosa, Livia Pisciotta, Carlo Barbagallo

Research output: Contribution to journalArticle


The main guidelines for cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both red yeast rice and polyunsaturated fatty acids (PUFAs) and a phytosterol-based approach in a setting of clinical practice. This was a multicenter open study with parallel control. We consecutively enrolled 107 pharmacologically untreated subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome, assigned to 8-week treatment with a combined treatment with red yeast rice (Dif1Stat®, including 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6±13.6mg/dL), triglycerides (TG; -19.8±25.1mg/dL), and non-HDL-C (-43.1±17.7mg/dL) (all P

Original languageEnglish
Pages (from-to)1270-1273
Number of pages4
JournalJournal of Medicinal Food
Issue number11
Publication statusPublished - Nov 1 2015



  • Dietary supplements
  • Hypercholesterolemia
  • Monacolins
  • Nutraceuticals
  • Phytosterols
  • PUFA
  • Red yeast rice

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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