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

Abstract

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 K2 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 (p = 0.083), LDL cholesterol (p = 0.150), and triglycerides (p = 0.822). No changes were found in hs-CRP (p = 0.179), interleukin-32 (p = 0.587), interleukin-38 (p = 0.930), miR-21 (p = 0.275), miR-126 (p = 0.718), miR-146a (p = 0.206), myoglobin (p = 0.164), and creatine kinase (p = 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.

Dietary Epigenetic Modulators: Unravelling the Still-Controversial Benefits of miRNAs in Nutrition and Disease

“…The effects of 4-week time-restricted eating (TRE), a popular form of intermittent fasting, determined downregulation of a miRNA panel (miR-4649-5p, miR-2467-3p, miR-543, miR-301a-3p, miR-3132, miR-19a-5p, miR-495-3p, and miR-4761-3p), which, in turn, could inhibit cell growth pathways while activating cell survival and promoting healthy aging (NCT03590847) [ 152 ]. A study conducted on 125 subjects with hypercholesterolemia (ACTRN12619000170123) evaluated the effect of daily assumption of a nutraceutical combination containing 400 mg phytosterols, 100 mg bergamot extract, 20 mg olive extract, and 52 µM vitamin K2 up to 12 weeks of treatment [ 153 ]. The evaluated nutraceutical combination did not change the serum lipid profile and inflammation-related miRNAs and biomarkers [ 153 ].…”

“…A study conducted on 125 subjects with hypercholesterolemia (ACTRN12619000170123) evaluated the effect of daily assumption of a nutraceutical combination containing 400 mg phytosterols, 100 mg bergamot extract, 20 mg olive extract, and 52 µM vitamin K2 up to 12 weeks of treatment [ 153 ]. The evaluated nutraceutical combination did not change the serum lipid profile and inflammation-related miRNAs and biomarkers [ 153 ].…”

Anti-Inflammatory Effects of Lipid-Lowering Drugs and Supplements—A Narrative Review

“…The same trial demonstrated a decrease in levels of matrix metalloproteinases (MMPs) 2 and 9, which are considered markers of atherosclerotic plaque stability [ 219 ]. Moreover, monacolin K in nutraceutical combination with phytosterols, hydroxytyrosol, and vitamin E confirmed reduction in LDL-C and hsCRP levels in subjects with previously untreated hypercholesterolemia and low or moderate cardiovascular risk [ 220 ], while monacolin K-free combination did not demonstrate analogous results [ 221 ]. Ferulic acid supplementation reduced LDL-C, oxidized LDL-C, hsCRP, and TNF-α, as well as other lipids, oxidative stress, and inflammatory biomarkers in hyperlipidemic subjects [ 222 ].…”