Experimental pasta as an innovative approach to cholesterol reduction in patients with metabolic syndrome, with and without major psychiatric disorders: A randomized controlled trial supported by in vitro validation.

BACKGROUND

Elevated non-high-density lipoprotein cholesterol (non-HDL-C) is a significant risk factor for atherosclerotic cardiovascular diseases, particularly in individuals with metabolic syndrome (MetS) and major psychiatric disorders (MPDs), who may experience metabolic side effects of psychopharmacological treatments. We evaluated the cholesterol-lowering effects of an experimental pasta characterized by a high content of phytosterols, arabinoxylans, polyunsaturated and monounsaturated fatty acids, and vitamin E in individuals with MetS, with and without MPDs.

METHODS

In a double-blind, randomized trial, 298 participants with MetS were assigned to consume either experimental or conventional pasta for 3 months. Non-HDL-C levels were measured at baseline and follow-up. A polygenic risk score for hypercholesterolemia (TC-PRS) was calculated to assess any genetic influence on the intervention's efficacy. The cholesterol-lowering effect of the experimental pasta was also tested in vitro by exposing human hepatocarcinoma cells, which developed lipid storage alterations due to olanzapine (OLZ) exposure, to an extract of the flour mixture used to prepare the experimental pasta.

RESULTS

The participants who consumed the experimental pasta exhibited a significantly greater reduction in serum non-HDL-C levels compared to the control group (p = 0.001). No significant interaction between pasta variety and the TC-PRS on non-HDL-C changes was found. The extract from the experimental flour mixture significantly reduced both the number and size of lipid droplets in HepG2 cells treated with OLZ.

CONCLUSIONS

These results indicate that a low-impact lifestyle intervention may offer a practical strategy for improving the cholesterol profile and mitigating cardiovascular risk in patients with MetS, with and without an MPD.