Abstract
BackgroundElevated 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.MethodsThe 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry: ACTRN12619000170123. Retrospectively registered on 5 February 2019
Highlights
Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression
Elevated serum cholesterol concentrations are one of the main risk factors for atherosclerosis progression that can lead to myocardial infarction, stroke, and peripheral vascular disease
Our study describes the protocol of a clinical trial, designed for evaluation of the effects of a new dietary supplement on total cholesterol levels in patients with mild hypercholesterolemia
Summary
Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Elevated serum cholesterol concentrations (hypercholesterolemia) are one of the main risk factors for atherosclerosis progression that can lead to myocardial infarction, stroke, and peripheral vascular disease. Patients with indications for the statin therapy as primary prevention most often prefer not to take the drugs for possible side effects and attempt to reduce the total cholesterol levels in serum by improving their lifestyle. The lifestyle changes recommended are smoking cessation, no alcohol consumption, increasing physical activity, and maintaining a healthy weight [3]. When all these efforts do not give results, the intake of nutraceutical substances could be considered in improving the lipid profile
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