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Avicenna Journal of Phytomedicine، جلد ۱۲، شماره ۶، صفحات ۵۵۹-۵۶۵
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عنوان انگلیسی An open-label study on the short-term effects of a novel EFSA-compliant nutraceutical combination in mild-to-moderate hypercholesterolemia
چکیده انگلیسی مقاله Objective: Recently, the European Food Safety Authority (EFSA) has recommended to limit the use of total monacolins in red yeast rice (RYR) products to a dose < 3 mg/day. However, data concerning the lipid lowering efficacy of the reduced dosage remain limited. A monacolin dose reduced due to safety issues may be expected to be less effective as a lipid lowering strategy and, for this reason, nutraceutical combinations with other active compounds may offer a viable solution as they can act synergistically through different mechanisms.Materials and Methods: This 8-week open-label study was designed to investigate the safety and efficacy of a novel ESFA-compliant lipid lowering nutraceutical combination (Colestarmony Plus®; containing total monacolins from RYR at a dose of 2.9 mg/day, a highly bioavailable berberine formulation, and pomegranate extract) in subjects (n=40) with mild-to-moderate hypercholesterolemia and no history of cardiovascular disease.Results: After 8 weeks of supplementation, Colestarmony Plus® significantly reduced total cholesterol (−10.4%, p< 0.05), low-density lipoprotein cholesterol (−14.8%, p< 0.05), oxidized low-density lipoprotein cholesterol (−12.0%, p< 0.05), and high-sensitivity C-reactive protein (−14.0%, p< 0.05) compared with baseline values. A subgroup of 22 patients underwent measurements of flow-mediated dilation, with values increasing by 18.0% at 8 weeks with respect to baseline (p< 0.05). The supplement was generally well-tolerated.Conclusion: Our short-term results indicate that the tested ESFA-compliant nutraceutical is effective in a primary prevention setting, even by providing only < 3 mg/day of monacolins.
کلیدواژه‌های انگلیسی مقاله Monacolins, Berberine, Pomegranate, Nutraceutical, Hypercholesterolemia, Primary prevention
نویسندگان مقاله | Piercarlo Minoretti
Studio Minoretti, Oggiono (LC), Italy


| Marco Biagi
Department of Environment, Earth and Physical Sciences, University of Siena, Siena, Italy


| Enzo Emanuele
2E Science, Robbio (PV), Italy
نشانی اینترنتی https://ajp.mums.ac.ir/article_20662.html
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زبان مقاله منتشر شده en
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نوع مقاله منتشر شده Short communication
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