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

Domenech, Mònica, Casas, Rosa, Ruiz-León, Ana Maria, Sobrino, Javier, Ros, Emilio, Estruch, Ramon
Nutrients 2019 v.11 no.5
C-reactive protein, adverse effects, apolipoprotein B, biomarkers, blood pressure, fasting, glucose, hypercholesterolemia, inflammation, interleukin-6, lipid composition, liver, lovastatin, low density lipoprotein cholesterol, men, muscles, phytosterols, placebos, red yeast rice, women
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&reg;) 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&reg; is useful for reducing total cholesterol, LDL-c, and inflammation in individuals with moderate hypercholesterolemia.