Effect of combined lipid-lowering and antioxidant nutraceutical on plasma lipids, endothelial function, and estimated cardiovascular disease risk in moderately hypercholesterolemic patients: a double-blind, placebo-controlled randomized clinical trial
| Autor: | Raffaele Ivan Cincione, Federica Fogacci, Arrigo F G Cicero, Maddalena Veronesi, Marilisa Bove |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Cholesterol business.industry monacolins General Medicine Placebo Gastroenterology Camellia sinensis law.invention dietary supplements Clinical trial chemistry.chemical_compound Nutraceutical chemistry Randomized controlled trial Clinical Research law Internal medicine medicine Red yeast rice cardiovascular benefit Olea europaea business Niacin Lipoprotein |
| Zdroj: | Archives of Medical Sciences. Atherosclerotic Diseases |
| ISSN: | 2451-0629 |
| DOI: | 10.5114/amsad.2021.107843 |
| Popis: | IntroductionNutraceuticals are a good means to lower cardiovascular risk. Having established a reasonable pharmacological background, a new nutraceutical combination should be tested in clinical trials.Material and methodsThis double-blind, placebo-controlled randomized clinical trial aims to evaluate the modulating effect, in a setting of controlled nutritional habits, of a combined food supplement with DIF1STAT (based on red yeast rice with a very low content of monacolins, linear aliphatic alcohols and niacin) and Olea europaea on plasma lipids and endothelial function, in a group of 40 healthy, moderately hypercholesterolemic patients in primary cardiovascular prevention.ResultsAfter 8 weeks of treatment, when compared to the placebo group, the active treated patients experienced significant improvements of different metabolic parameters and endothelial reactivity compared to placebo. The treated patients showed a statistically significant percentage change in total cholesterol (–12.25 delta% vs. –1.8%, p < 0.01), low-density lipoprotein (LDL) cholesterol (–28.7 delta% vs. –1.1%, p < 0.01), high-density lipoprotein (HDL) cholesterol (+4.99% vs. +0.9%, p < 0.05), non-HDL cholesterol (–16.02 delta% vs. –1.5%, p < 0.01), SUA (–12.96 delta%, p < 0.05) and endothelial reactivity (+6.73% vs. –1.4%, p < 0.01). In both groups, there was no case of intolerance and the safety parameters were unchanged.ConclusionsThe tested nutraceutical association is able to significantly improve different lipid parameters compared to placebo, and endothelial reactivity compared to baseline. Even if the study power appears to be adequate for the primary endpoints, the effect on endothelial function needs confirmation in a longer clinical trial. |
| Databáze: | OpenAIRE |
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