Food Supplement for Individuals With Polygenic Hypercholesterolaemia

Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk. Non-HDL-C provides a comprehensive estimate of atherogenic cholesterol burden. In primary prevention, adults with polygenic hypercholesterolaemia often require dietary and lifestyle interventions, but these may not yield sufficient lipid improvements. This study evaluates the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, versus placebo, on non-HDL-C change in adults with polygenic hypercholesterolaemia. The three-arm design assesses the primary placebo-controlled comparison and the incremental effect of the combined formulation. Secondary analyses explore changes in lipid fractions and inflammatory indices. An open-label extension evaluates changes through 12 weeks. The goal is to provide evidence for well-tolerated adjunctive options for lipid management.

Inclusion Criteria: * Male or female aged ≥ 18 years and ≤ 75 years old; * Subjects in primary prevention for cardiovascular diseases; * Estimated 10-year cardiovascular risk \< 10%; * Screening lipid levels meeting at least one of the following criteria: * non-HDL cholesterol between 145 and 220 mg/dL, OR * LDL cholesterol between 115 and 190 mg/dL; * Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements; * Subjects willing to participate in the study and having dated and signed the informed consent form. Exclusion Criteria: * Triglycerides \> 400 mg/dL at screening; * Type 1 or type 2 diabetes mellitus; * Current treatment with lipid-lowering drugs; * Known clinically significant alterations of hepatic and/or renal function; * Women of childbearing potential not using adequate contraceptive methods; * Pregnancy and breastfeeding; * Any medical or surgical condition that could make adherence to the protocol complex or inconsistent, or could compromise subject safety or the ability to complete the study; * Known intolerance/hypersensitivity to any component of the investigational products.