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标题：Randomized, Double-Blind, Placebo-Controlled Trial to Test the Effects of a Nutraceutical Combination Monacolin K-Free on the Lipid and Inflammatory Profile of Subjects with Hypercholesterolemia
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作者：Olga Protic ; Raffaele Di Pillo ; Alberto Montesanto 等
期刊名称：Nutrients
电子版ISSN：2072-6643
出版年度：2022
卷号：14
期号：14
DOI：10.3390/nu14142812
语种：English
出版社：MDPI Publishing
摘要：Background: Nutraceutical combinations (NCs) against hypercholesterolemia are increasing in the marketplace. However, the availability of NCs without monacolin K is scarce even though the statin-intolerant population needs it. Methods: This study is a parallel-group, randomized, placebo-controlled, double-blind trial. We evaluated the effects of the NC containing phytosterols, bergamot, olive fruits, and vitamin K 2 on lipid profile and inflammatory biomarkers in 118 subjects (mean age ± SD, 57.9 ± 8.8 years; 49 men and 69 women) with hypercholesterolemia (mean total cholesterol ± SD, 227.4 ± 20.8 mg/dL) without clinical history of cardiovascular diseases. At baseline and 6 and 12 weeks of treatment, we evaluated lipid profile (total, LDL and HDL cholesterol, and triglycerides), safety (liver, kidney, and muscle parameters), and inflammatory biomarkers such as hs-CRP, leukocytes, interleukin-32, and interleukin-38 and inflammatory-microRNAs (miRs) miR-21, miR-126, and miR-146a. Results: Compared to the placebo, at 6 and 12 weeks, NC did not significantly reduce total cholesterol ( p = 0.083), LDL cholesterol ( p = 0.150), and triglycerides ( p = 0.822). No changes were found in hs-CRP ( p = 0.179), interleukin-32 ( p = 0.587), interleukin-38 ( p = 0.930), miR-21 ( p = 0.275), miR-126 ( p = 0.718), miR-146a ( p = 0.206), myoglobin ( p = 0.164), and creatine kinase ( p = 0.376). Among the two reported, only one adverse event was probably related to the nutraceutical treatment. Conclusions: The evaluated nutraceutical combination did not change serum lipid profile and inflammatory parameters, at least not with the daily dose applied in the present study.
关键词：endietary supplementnutraceutical combinationmonacolin K-freelipid profileinflammatory profilehypercholesterolemia