Atherosclerotic cardiovascular disease (ASCVD) remains the major mortality cause in the developed countries with hypercholesterolaemia being one of the primary modifiable causes. Lifestyle intervention constitutes the first step in cholesterol management and includes dietary modifications along with the use of functional foods and supplements.

Functional foods enriched with plants sterols/stanols have become the most widely used non‐prescription cholesterol-lowering approach, despite the lack of randomized trials investigating their long-term safety and cardiovascular efficacy. The cholesterol-lowering effect of plant sterol supplementation is well-established and a potential beneficial impact on other lipoproteins and glucose homeostasis has been described. Nevertheless, experimental and human observational studies investigating the association of phytosterol supplementation or circulating plant sterols with various markers of atherosclerosis and ASCVD events have demonstrated controversial results. Compelling evidence from recent genetic studies have also linked elevated plasma concentrations of circulating plant sterols with ASCVD presence, thus raising concerns about the safety of phytosterol supplementation. 

Considering the lack and the inability to design randomized clinical trials addressing cardiovascular efficacy and safety, future studies could clarify whether the relatively small increase in the plasma concentration of circulating phytosterols induced by phytosterol enriched food attenuates atherosclerosis and increases cardiovascular disease (CVD) risk. In the meantime, both physicians and consumers should keep in mind that this recommendation might be applied to individuals with hypercholesterolaemia, who are expected to have a cardiovascular benefit, but also that the daily intake must not exceed the recommended dose. Finally, plant sterols/stanols should not be viewed as a substitute for much more effective and evidence-based cholesterol-lowering therapies, especially in individuals at high CVD risk.