Phytosterols are highly safe, with health claims approved by EFSA and FDA for reducing LDL and total cholesterol.
The FDA recommends a minimum intake of 0.65 g twice daily to help maintain normal blood cholesterol levels. EFSA recommends at least 0.8 g per day.
Clinical trials show β-sitosterol doses of 0.6–1.1 g/day reduce cholesterol by >5%, while 3.3 g/day achieves reductions >12%. Caresterol has demostrated improved activity in vivo.
To better understand the differences between Caresterol and other traditional solutions such as Red Yeast Rice, it is important to examine their mechanisms of action, safety profiles, additional benefits, and stability.
While Caresterol combines β-sitosterol and propionic acid to block cholesterol absorption and improve its bioavailability, Red Yeast Rice works by inhibiting cholesterol synthesis through monacolins but may cause side effects that limit its safe use.
In cases where standard β-sitosterol fails to prevent cholesterol elevation, CIRCE β-sitosterol continues to exhibit a substantial cholesterol-lowering effect.
Caresterol hypolipidemic activity vs. β-sitosterol. In vivo study (22 days analysis in hamsters with obesogenic diet, giving an equivalent to human dose of free β-sitosterol).
Caresterol demonstrates significant ability to reduce fatty liver disease (NAFLD) biomarkers in an obesogenic diet.
Caresterol has shown other effects that could be of interest for new developments or claims: the cocrystals seem to decrease levels of hepatosteatosis markers at a standard human dose, as the animals (hamsters) treated with Caresterol had lower GPT levels.
In contrast to standard sitosterol, which does not prevent weight gain in an obesogenic diet, Caresterol exhibits a substantial effect on reducing weight gain.
Caresterol showed an improved effect on obesity: after 20 days of treatment, the increase in body weight was lower in animals treated with the Caresterol and showed a higher proportion of small adipocytes.
Caresterol is also commonly used in the long-term treatment of BPH (benign prostatic hyperplasia) and in hair loss prevention at much lower doses (between 60 mg to 300 mg per day), but FDA or EFSA has not granted specific health claims for these uses yet. Industrial scale batches of Caresterol have already been produced under GMP in Spain from a natural plant phytosterol. Samples and technical information are already available.