1. Efficacy of a nutraceutical combination on lipid metabolism in patients with metabolic syndrome: A multicenter, double blind, randomized, placebo controlled trial
- Author
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Giampaolo Giacovelli, Cristina Vitalini, Ferruccio Galletti, Francesca Battista, Giorgio Bosso, Giacomo Pucci, Valentina Mercurio, Massimo D'Amato, Valeria Fazio, Marco Gentile, Giuseppe Schillaci, Domenico Bonaduce, Nadia Brambilla, Galletti, F., Fazio, V., Gentile, M., Schillaci, G., Pucci, G., Battista, F., Mercurio, V., Bosso, G., Bonaduce, D., Brambilla, N., Vitalini, C., D'Amato, M., and Giacovelli, G.
- Subjects
Male ,Berberine ,Endocrinology, Diabetes and Metabolism ,Clinical Biochemistry ,Placebo-controlled study ,030204 cardiovascular system & hematology ,Fatty Alcohol ,Gastroenterology ,Placebos ,chemistry.chemical_compound ,0302 clinical medicine ,Endocrinology ,High-density lipoprotein ,lcsh:RC620-627 ,Metabolic Syndrome ,education.field_of_study ,medicine.diagnostic_test ,Middle Aged ,Left Ventricular ,lcsh:Nutritional diseases. Deficiency diseases ,Cholesterol ,Treatment Outcome ,Hypertrophy, Left Ventricular ,Female ,Fatty Alcohols ,Human ,medicine.drug ,Adult ,medicine.medical_specialty ,Population ,030209 endocrinology & metabolism ,Placebo ,LDL ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Lovastatin ,education ,Policosanol ,Aged ,business.industry ,Research ,Biochemistry (medical) ,Cholesterol, LDL ,Hypertrophy ,medicine.disease ,Lipid Metabolism ,chemistry ,Insulin Resistance ,Dietary Supplements ,Metabolic syndrome ,Lipid profile ,business - Abstract
Background Nutraceuticals 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. Methods The 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. Results After 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
- Published
- 2019