An open-label study on the short-term effects of a novel EFSA-compliant nutraceutical combination in mild-to-moderate hypercholesterolemia | ||
| Avicenna Journal of Phytomedicine | ||
| دوره 12، شماره 6، بهمن و اسفند 2022، صفحه 559-565 اصل مقاله (413.78 K) | ||
| نوع مقاله: Short communication | ||
| شناسه دیجیتال (DOI): 10.22038/ajp.2022.20662 | ||
| نویسندگان | ||
| Piercarlo Minoretti1؛ Marco Biagi2؛ Enzo Emanuele* 3 | ||
| 1Studio Minoretti, Oggiono (LC), Italy | ||
| 2Department of Environment, Earth and Physical Sciences, University of Siena, Siena, Italy | ||
| 32E Science, Robbio (PV), Italy | ||
| چکیده | ||
| 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. | ||
| کلیدواژهها | ||
| Monacolins؛ Berberine؛ Pomegranate؛ Nutraceutical؛ Hypercholesterolemia؛ Primary prevention | ||
| مراجع | ||
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