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

Abstract

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 5 mg monacolin K) and 610 mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600 mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50 ± 18.1 mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6 ± 13.6 mg/dL), triglycerides (TG; -19.8 ± 25.1 mg/dL), and non-HDL-C (-43.1 ± 17.7 mg/dL) (all P < .001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7 ± 4.3 mg/dL), LDL-C (-17.6 ± 8.5 mg/dL), and non-HDL-C (-14.1 ± 5.6 mg/dL) (all P < .001). When comparing the combined nutraceutical effect with that of phytosterols, we observed that the combined nutraceutical intake was associated with a significantly higher decrease in TC, LDL-C, TG, and non-HDL-C (all P < .001). In the short term, a combined nutraceutical containing red yeast rice and PUFAs is well tolerated and efficacious in reducing plasma lipid levels in subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome.

• Authors: Arrigo F G Cicero, Giuseppe Derosa, Livia Pisciotta, Carlo Barbagallo, SISA-PUFACOL Study Group
• Journal: Journal of medicinal food (J Med Food) Vol. 18 Issue 11 Pg. 1270-3 (Nov 2015) ISSN: 1557-7600 [Electronic] United States
• PMID: 26274827 (Publication Type: Controlled Clinical Trial, Journal Article)

Chemical References

• Anticholesteremic Agents
• Biological Products
• Cholesterol, LDL
• Fatty Acids, Unsaturated
• Lipids
• Phytosterols
• Triglycerides
• red yeast rice
• Cholesterol
• Lovastatin

Topics

• Adult
• Anticholesteremic Agents (pharmacology, therapeutic use)
• Biological Products (chemistry, pharmacology, therapeutic use)
• Cholesterol (blood)
• Cholesterol, LDL (blood)
• Dietary Supplements
• Fatty Acids, Unsaturated (pharmacology, therapeutic use)
• Female
• Humans
• Hypercholesterolemia (blood, complications, drug therapy)
• Lipids (blood)
• Lovastatin (pharmacology, therapeutic use)
• Male
• Metabolic Syndrome (blood, complications, drug therapy)
• Middle Aged
• Phytosterols (pharmacology, therapeutic use)
• Treatment Outcome
• Triglycerides (blood)