Abstract
BackgroundNutraceuticals represent a new therapeutic frontier in the treatment of metabolic syndrom (MetS) and related cardiovascular risk factors. The aim of this study was to evaluate the potential beneficial effects of Armolipid Plus (AP) (berberine 500 mg, red yest rice, monacolin K 3 mg and policosanol 10 mg) on insulin resistance, lipid profile, particularly on small and dense LDL cholesterol (sdLDL-C), representing the most atherogenic components, as well as its effects on high sensitivity C-reactive protein, a notable marker of cardiovascular risk, blood pressure and cardiac remodeling in subjects affected by MetS, with left ventricular hypertrophy.MethodsThe study was a prospective, multi-center, randomized, double blind, placebo-controlled trial. One hundred and fifty eight patients, aged between 28 and 76 years old, were enrolled and randomized to receive either one tablet of AP or placebo (PL) once daily for 24 weeks. Anthropometric and vital parameters, total cholesterol (tot-C), low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceridemia (TG), non-HDL cholesterol (NHDL-C) and sdLDL-C were evaluated.ResultsAfter 24 weeks of treatment, the analysis performed on 141 subjects (71 in AP arm and 70 in PL arm), showed a significant improvement of lipid profile in the AP group, with reduction in tot-C (− 13.2 mg/dl), LDL-C (− 13.9 mg/dl) and NHDL-C (− 15.3 mg/dl) and increase in HDL-C (+ 2.0 mg/dl). These changes were equally significant compared with placebo (tot-C: AP − 13.2 mg/dL vs PL + 2.7 mg/dL, p < 0.01; LDL-C: AP -13.9 mg/dl vs PL + 1.5 mg/dl, p < 0.01; NHDL-C: AP -15.3 mg/dl vs PL + 2.8 mg/dl, p < 0.01), Although no significant difference was observed between the two arms in the reduction of HDL-C nevertheless it increased significantly in the AP group (AP + 2 mg/dL p < 0.05, PL 0.13 mg/dL).ConclusionThe results of this study, applicable to a specific local population show that, in a population of subjects affected by MetS, treatment with AP improves the lipid profile and the most atherogenic factors, thus suggesting a reduction in the risk of development and progression of atherosclerosis, particularly in subjects with high atherogenic risk, due to the presence of sdLDL-C.
Highlights
Metabolic syndrome (MetS) is a common clinical condition in the western world, associated with an increased risk for cardiovascular disease (CVD) [1, 2]. This condition is characterized by visceral obesity, high blood pressure values and insulin resistance (IR), which promotes an atherogenic lipid profile, with raised triglycerides (TG), elevated very low density lipoprotein cholesterol (VLDL-C) and decreased high density lipoprotein cholesterol (HDL-C), which translates into an increase in non-HDL cholesterol (NHDL-C)
In the placebo group 44 patients were being treated with statins
Of the remaining 17, 5 patients did not have laboratory parameters analyzed from coordinating center, whereas 12 patients prematurely discontinued the study (4 because of protocol violation of inclusion/exclusion criteria, 7 due to withdrawal of consent and 1 patient, in Armolipid Plus (AP) group, due to non-serious adverse events related to the treatment) (Fig. 1)
Summary
Metabolic syndrome (MetS) is a common clinical condition in the western world, associated with an increased risk for cardiovascular disease (CVD) [1, 2] This condition is characterized by visceral obesity, high blood pressure values and insulin resistance (IR), which promotes an atherogenic lipid profile, with raised triglycerides (TG), elevated very low density lipoprotein cholesterol (VLDL-C) and decreased high density lipoprotein cholesterol (HDL-C), which translates into an increase in non-HDL cholesterol (NHDL-C). Insulin resistance is a state in which physiological amount of insulin has a reduced effect on post-prandial glicemic control with an inadequate insulin suppression during the night period It is counteracted by increasing the release of insulin to maintain normal glucose serum value. The aim of this study was to evaluate the potential beneficial effects of Armolipid Plus (AP) (berberine 500 mg, red yest rice, monacolin K 3 mg and policosanol 10 mg) on insulin resistance, lipid profile, on small and dense LDL cholesterol (sdLDL-C), representing the most atherogenic components, as well as its effects on high sensitivity C-reactive protein, a notable marker of cardiovascular risk, blood pressure and cardiac remodeling in subjects affected by MetS, with left ventricular hypertrophy
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