Randomized, Double-Blind, Placebo-Controlled Trial to Test the Effects of a Nutraceutical Combination Monacolin K-Free on the Lipid and Inflammatory Profile of Subjects with Hypercholesterolemia.

BACKGROUND

Nutraceutical combinations (NCs) against hypercholesterolemia are increasing in the marketplace. However, the availability of NCs without monacolin K is scarce even though the statin-intolerant population needs it.

METHODS

This study is a parallel-group, randomized, placebo-controlled, double-blind trial. We evaluated the effects of the NC containing phytosterols, bergamot, olive fruits, and vitamin K on lipid profile and inflammatory biomarkers in 118 subjects (mean age ± SD, 57.9 ± 8.8 years; 49 men and 69 women) with hypercholesterolemia (mean total cholesterol ± SD, 227.4 ± 20.8 mg/dL) without clinical history of cardiovascular diseases. At baseline and 6 and 12 weeks of treatment, we evaluated lipid profile (total, LDL and HDL cholesterol, and triglycerides), safety (liver, kidney, and muscle parameters), and inflammatory biomarkers such as hs-CRP, leukocytes, interleukin-32, and interleukin-38 and inflammatory-microRNAs (miRs) miR-21, miR-126, and miR-146a.

RESULTS

Compared to the placebo, at 6 and 12 weeks, NC did not significantly reduce total cholesterol ( = 0.083), LDL cholesterol ( = 0.150), and triglycerides ( = 0.822). No changes were found in hs-CRP ( = 0.179), interleukin-32 ( = 0.587), interleukin-38 ( = 0.930), miR-21 ( = 0.275), miR-126 ( = 0.718), miR-146a ( = 0.206), myoglobin ( = 0.164), and creatine kinase ( = 0.376). Among the two reported, only one adverse event was probably related to the nutraceutical treatment.

CONCLUSIONS

The evaluated nutraceutical combination did not change serum lipid profile and inflammatory parameters, at least not with the daily dose applied in the present study.