Effectiveness and Safety of Dietetic Supplementation of a New Nutraceutical on Lipid Profile and Serum Inflammation Biomarkers in Hypercholesterolemic Patients

Background: To assess the effectiveness and safety of a new nutraceutical (NC) on lipid profile, inflammation biomarkers and creatine phosphokinase (CPK) serum levels in hypercholesterolemic patients. Methods: 40 patients underwent hypolipemic treatment with NC. Initial and final (after 12 weeks) screening included medical history, physical examination, and measurement of serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides), hepatic (GOT, GPT, GT), and renal (serum creatinine and urea) functions, CPK level and many inflammation biomarkers (hs-CRP and fibrinogen). At the screening visit, all patients were instructed to follow a normocaloric and hypolipidic diet during the study period. Results: The treatment with supplementation of NC demonstrated a significant reduction of serum total cholesterol (224 +/- 11.2 mg/dL vs. 178 +/- 10.7; p < 0.001), LDL-cholesterol (141 +/- 10.6 vs. 116 + 10.1; p < 0.001), triglycerides (183 +/- 13 vs. 159 +/- 11.5; p < 0.01), serum inflammatory biomarkers as hs-CRP (2.24 +/- 0.83 vs. 1.76 +/- 0.61 mg/dL; p < 0.01), fibrinogen (315 +/- 43 vs. 199 +/- 41 mg/dL; p < 0.01) and a significantly increase of HDL-cholesterol (44 +/- 7 vs. 53 +/- 7 mg/dL; p < 0.01). Hepatic and renal function and serum CPK were normal. No adverse events was reported. Conclusions: The treatment with NC has demonstrated a significant reduction of LDL-cholesterol (-17.73%), total cholesterol (-20.53%) and triglycerides (-13.1%), with a significant increase of HDL-cholesterol values (+20.45%). The improvement of lipid profile was associated with a significant reduction of serum inflammation biomarkers as hs-PCR (-27%) and fibrinogen (-36.8%) with good tolerability profile.