Lipid-lowering Potential of a Complex Dietary Supplement for Cholesterol Control and Vascular Protection

Abstract

The objective: to analyze the lipid-lowering effect of a complex dietary supplement containing red fermented rice extract, bergamot extract and 5-methyltetrahydrofolate in patients with low, moderate and high cardiovascular risk (CVR) or patients who refused to use statins. Materials and methods. The open-label post-marketing study included 60 patients aged 48.1±0.7 years, 54 (90%) persons of whom were women. According to the results of the assessment of total CVR, most patients were in the low/moderate and high risk categories – 47 (78.3%) and 13 (21.7%) individuals, respectively, the last patients refused to use statins. Overweight and obesity were detected in 50% of the study participants – 24 (40%) and 6 (10%) people with degree I obesity, respectively. Arterial hypertension with a grade 1 increase in blood pressure was present in 45% of the study participants (27 persons, all women). Patients were prescribed a complex dietary supplement containing red fermented rice extract, bergamot extract, and 5-methyltetrahydrofolate in clearly defined doses for 3 months. At the screening stage and the final visit all patients underwent a general clinical and laboratory examination. Results. The use of a complex dietary supplement for cholesterol control and vascular protection for 3 months contributed to a decrease in total cholesterol (TC) by 8.1% (p=0.0001), low-density lipoprotein cholesterol (LDL-C) by 14.3% (p=0.0001), non-HDL-C by 12.5% (p=0.0001) and an increase in high-density lipoprotein cholesterol (HDL-C) by 7.1% (p=0.02). In patients with a baseline triglyceride (TG) level (>1.7 mmol/l), a significant reduction of 18.5% (p=0.04) was found, and in patients with signs of systemic inflammation the level of C-reactive protein (CRP) was >3 mg/ml. The use of a dietary supplement helped to reduce CRP by 33.3% (p=0.008). Positive dynamics of the albumin to creatinine ratio in patients with more severe albuminuria was determined. The results of the study indicate that the use of a dietary supplement containing red fermented rice extract, bergamot extract and 5-methyltetrahydrofolate does not affect carbohydrate metabolism and liver function tests. Conclusions. A dietary supplement containing a scientifically based combination of substances of natural origin for the normalization of lipid profile has a positive effect on lipid profile parameters, contributing to a decrease in LDL-C and TG levels in individuals with baseline hypertriglyceridemia and an increase in HDL-C content. The dietary supplement, which contains red fermented rice extract, bergamot extract and 5-methyltetrahydrofolate, improves endothelial function, as evidenced by a decrease in albuminuria and low-grade systemic inflammation in individuals with higher baseline vaules.