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Background: Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering and inflammation-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. Here, we describe the study protocol of a clinical trial aimed to evaluate the cholesterol and inflammatory lowering effect of an innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits in association with vitamin K2 in subjects with mild hypercholesterolemia.Methods: The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age ≥ 40 years) with mild hypercholesterolemia (total serum cholesterol levels ≥ 200 and ≤ 250 mg/dl) will be recruited. Intervention arm participants will take one capsule of dietary supplement two times a day, 15 min before the main meal. Control arm participants will receive one capsule of placebo in the same way. The dietary supplement capsule contains the following ingredients: phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2. Participants will undergo a medical evaluation and chemical-clinical examinations, which include lipid profile, glycemia, biomarkers of renal, liver and cardiac/muscular functions, interleukins (IL 6, IL-32, IL-37, and IL-38), and innovative mediators of inflammation such as inflamma-miRs (miR-21 and miR-146a), at baseline, and after 6 and 12 weeks of treatment. The decrease in total cholesterol levels and inflammatory biomarkers will be the primary and secondary endpoints of the study.Discussion: This protocol study, planned to verify the effects of BruMeChol™ dietary supplementation in subjects with mild hypercholesterolemia, could also contribute to new study designs for next large-scale multicenter clinical trials.Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12619000170123 . Retrospectively registered on 5 February 2019. [ABSTRACT FROM AUTHOR]

Oxidative stress and reactive oxygen species (ROS) constitute a major pathogenic mechanism for the development of atherosclerosis. In the present work, the antioxidant potential of Trihoney was investigated in hypercholesterolaemic rabbits. Thirty-six male New Zealand white (NZW) rabbits were grouped into: normal diet (C), normal diet with 0.6 g/kg/day of Trihoney (C+H), 1% cholesterol diet (HCD), 1% cholesterol diet with 0.3 g/kg/day of Trihoney (HCD+H1), 1% cholesterol diet with 0.6 g/kg/day of Trihoney (HCD+H2), and 1% cholesterol diet with 2 mg/kg/day of atorvastatin (HCD+At.). Animals were sacrificed following 12 weeks of treatment, and their serum was analysed for oxidised-low density lipoprotein (Ox-LDL). Serum and aortic tissue homogenate were assayed for superoxide dismutase (SOD), glutathione peroxidase (GPx), and malondialdehyde (MDA). Hypercholesterolemia caused a significant (p < 0.05) elevation in serum Ox-LDL and a significant (p < 0.05) reduction of antioxidant enzyme activities in serum of the HCD group. Trihoney induced a significant (p < 0.05) increase in antioxidant enzyme activities in serum as compared to the HCD group. The high cholesterol diet suppressed both antioxidant enzymes in aortic homogenate. Trihoney significantly (p < 0.05) enhanced both antioxidant enzymes in aortic homogenate. Hypercholesterolemia induced a significant (p < 0.05) elevation of serum lipid peroxidation in the HCD group. Trihoney caused a significant (p < 0.05) reduction of lipid peroxidation in aortic homogenate. These results demonstrated that Trihoney has the potential to ameliorate oxidative stress systemically, as well as locally in the atherosclerotic aorta. [ABSTRACT FROM AUTHOR]