Effects of a Novel Nutraceutical Combination (Aquilea Colesterol(®)) on the Lipid Profile and Inflammatory Biomarkers: A Randomized Control Trial.

BACKGROUND: Cholesterol-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. METHODS: In a parallel-group, randomized, placebo-controlled double-blind trial we evaluated the effects on plasma total cholesterol, low-density lipoprotein cholesterol (LDL-c), and inflammatory biomarkers of a nutraceutical combination (Aquilea Colesterol(®)) containing phytosterols (1.5 g), red yeast rice providing monacolin K (10 mg), hydroxytyrosol (5 mg), and plasma cholesterol values >5.17 mmol/L (>200 mg/dL) and LDL-c >2.97 mmol/L (>115 mg/dL). At baseline and at one and three months we recorded dietary habits; anthropometric parameters; blood pressure; lipid profile; fasting glucose; liver, renal, and muscle function tests, C-reactive protein (hs-CRP); and interleukin-6. RESULTS: 13 men and 27 women (mean age 61.8 years) completed the trial; 20 participants received the nutraceutical and 20 received placebo. No adverse effects were noted. Compared to placebo, at one and three months the nutraceutical reduced total cholesterol by 11.4% and 14.1%, LDL-c by 19.8% and 19.7%, and apolipoprotein B by 12.4% and 13.5%, respectively (p < 0.001; all). hs-CRP decreased significantly (p = 0.021) in the nutraceutical group. CONCLUSION: The nutraceutical Aquilea Colesterol(®) is useful for reducing total cholesterol, LDL-c, and inflammation in individuals with moderate hypercholesterolemia.