Background & aims: Cardiovascular diseases (CVDs) are the leading cause of global death. Hypercholesterolemia is among the main risk factors for developing cardiovascular events, and is highly prevalent in the Mexican population. The primary objective of the present work was to assess the effect of a dietary portfolio (DP) with functional foods containing dehydrated nopal, soy protein, chia seeds, inulin, and oats in LDL-C and TC concentrations of subjects with mild hypercholesterolemia. Also, we explored the changes in the profile of the lipoprotein subclasses measured by nuclear magnetic resonance spectroscopy (NMR). 

Methods: Sixty-two subjects (47 women, 15 men) with mild hypercholesterolemia (LDL-C, ≥130 ≤ 190 mg/dL, TC > 200 mg/dL) completed the randomized, parallel, controlled study. The dietary intervention was given in two stages. First, a dietary standardization stage with a low saturated fat diet (LSFD) which matched the habitual energy intake of the volunteers for 2-weeks, followed by 2.5 months of dietary intervention with a LSFD plus placebo (PL) or DP. 

Results: Subjects who consumed the LSFD + DP interventions had a significantly higher reduction of LDL-C (−18.05%, P = 0.003) and TC (−17.08%, P = 0.02) compared to volunteers who consumed an LSFD for the same period. Furthermore, the lipoprotein subclass profiling showed that the small low-density-lipoproteins, and the small high-density-lipoproteins significantly decreased (P = 0.04, P < 0.001, respectively), conveying a less atherogenic state. At the end of the study, 78% of the subjects who consumed LSFD + DP reduced their LDL-C below 160 mg/dL, and of these, 47% reduced it below 130 mg/dL. 

Conclusions: Based on the results obtained from this study, the inclusion of functional foods as part of the lifestyle modifications is recommended to treat mild hypercholesterolemia and reduce cardiovascular risk. 

Registered under ClinicalTrials.gov Identifier no. NCT04148976.