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Long-term efficacy and tolerability of a multicomponent lipid-lowering nutraceutical in overweight and normoweight patients

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Nutrafoods

Abstract

The short-term lipid-lowering activity of some nutraceuticals is well known, however there is a lack of knowledge about their long-term effect, especially regarding insulin-resistance parameters and biomarkers of vascular health. This study is a 12-month follow-up randomised clinical trial carried out on 269 non-smoker hyperlipidaemic patients in primary prevention for cardiovascular disease; 214 of them (129 men and 85 women) completed the trial with good compliance. None of the subjects were diabetics or had been treated with antihyperlipidaemic drugs. Seventy-nine normoweight subjects (Group 1) were treated with a combined nutraceutical monakolinberberine-policosand (MBP) mixture associated with a standardised therapeutic lifestyle (TLS) (as defined in the third Adult Treatment Panel of the National Cholesterol Education Program), 85 overweight subjects were treated with MBP-TLS (Group 2) and 50 overweight subjects only with intensified TLS (Group 3). Efficacy parameters (Body Mass Index, fasting plasma glucose, fasting plasma insulin, Homeostasis Model Assessment index, metalloproteinase-2 (MMP-2), MMP-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), TIMP-2, total cholesterol, low-density lipoprotein-C, high-density lipoprotein-C, triglyceride) were evaluated every 4 months. Educational reinforcements were also planned every 4 months. This study demonstrated the long-term efficacy and safety of a combined nutraceutical added to a TLS in overweight and normoweight dyslipidaemic subjects. Berberine- and red yeast rice-based nutraceuticals showed efficacy in body weight reduction and insulin-sensitivity promotion in non-diabetic hyperlipidaemic patients. Favourable effects of a combined nutraceutical in combination with a TLS were observed on biomarkers of vascular remodelling in overweight and normoweight dyslipidaemic subjects.

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Authors and Affiliations

  1. Internal Medicine, Aging and Kidney Disease Department, University of Bologna, Bologna, Italy

    Arrigo F. G. Cicero, Valeria De Sando, Danilo Benedetto, Matteo Cevenini, Elisa Grandi & Claudio Borghi

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  1. Arrigo F. G. Cicero
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  2. Valeria De Sando
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  3. Danilo Benedetto
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  4. Matteo Cevenini
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  5. Elisa Grandi
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  6. Claudio Borghi
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Correspondence to Arrigo F. G. Cicero.

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Cicero, A.F.G., De Sando, V., Benedetto, D. et al. Long-term efficacy and tolerability of a multicomponent lipid-lowering nutraceutical in overweight and normoweight patients. Nutrafoods 11, 55–61 (2012). https://doi.org/10.1007/s13749-012-0018-y

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  • DOI: https://doi.org/10.1007/s13749-012-0018-y

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