Abstract
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.
Highlights
To date, cardiovascular disease (CVD) continues to be the leading cause of morbidity and mortality worldwide [1]
This study was designed as a randomized, parallel-group, double-blind, placebo-controlled trial aimed to assess the efficacy of a novel nutraceutical combination (Aquilea Colesterol® ) that contains 1.5 g phytosterols, 10 mg monacolin K from red yeast rice (RYR), 5 mg hydroxytyrosol from olive leaf extract (Olea europaea), and 12 mg vitamin E in the reduction of total cholesterol and low-density lipoprotein cholesterol (LDL-c) in patients with primary hypercholesterolemia at low-to-moderate cardiovascular risk
Patients with mild-to-moderate hypercholesterolemia at low-toAccording to recent mild-to-moderate at moderate cardiovascular riskguidelines, who alreadypatients follow awith healthy diet and performhypercholesterolemia regular physical activity low-to-moderate cardiovascular risk who already follow a healthy diet and perform may be treated with cholesterol-lowering functional foods or nutraceuticals to helpregular achievephysical target activity may[3]
Summary
Cardiovascular disease (CVD) continues to be the leading cause of morbidity and mortality worldwide [1]. There is compelling evidence that elevated total cholesterol and low-density lipoprotein cholesterol (LDL-c) are causally related to CVD [2], signaling hypercholesterolemia as an important modifiable cardiovascular risk factor [3,4]. The European Society of Atherosclerosis and the European Society of Cardiology guidelines for the management of dyslipidemia state that supplementation with cholesterol-lowering functional foods or nutraceuticals might be indicated in this situation [3]. These compounds are appropriate alternatives for individuals with intolerance to statins or those who are not willing to take them [7]. At one and three months the nutraceutical reduced total cholesterol by
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