Phytosterols (mixed) have scientific support for their use in cardiovascular disease, particularly for managing hypercholesterolemia, which is a major risk factor for cardiovascular disease (CVD). Numerous randomized controlled trials and meta-analyses demonstrate that phytosterols—plant-derived sterols structurally similar to cholesterol—can lower low-density lipoprotein cholesterol (LDL-C) levels by 7-12% when consumed at doses of 2 grams per day. The mechanism involves phytosterols competing with dietary and biliary cholesterol for absorption in the intestines, thus reducing overall cholesterol uptake.

Regulatory authorities, including the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), have recognized the cholesterol-lowering effect of phytosterols and allow health claims regarding their benefit in reducing heart disease risk when used as part of a diet low in saturated fat and cholesterol. However, while the effect on LDL-C is well-established, direct evidence that phytosterol supplementation reduces the incidence of cardiovascular events (such as heart attacks or strokes) is limited, as most studies are biomarker-based rather than clinical outcome-based.

In summary, phytosterols are scientifically validated for lowering LDL cholesterol, which is an established surrogate marker for cardiovascular risk. Their use is widely recommended as part of dietary strategies to reduce CVD risk, but direct evidence on long-term cardiovascular outcomes is still an area of ongoing research.