A CLINICAL STUDY TO EVALUATE THE EFFICACY OF A NEW NEUTRACEUTICAL COMBINATION BASED ON RESVERATROL, BERBERISAND ASTRALAGUS EXTRACTS IN COMPARISIONTO A FORMULATION CONTAININGRED YEAST RICE (MONACOLIN K) IN PATIENTS WITH MODERATE DYSLIPIDEMIA

Background: Treatment strategies of dyslipidemia include pharmacologic and nonpharmacologic interventions though recently a relevant role has been shown for nutraceutical compoundsor specific functional ingredients in combination rather then in monotherapy. Objectives: The aim of this study was tocompare, in a randomized trial, the effects of two nutraceutical combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins and to evaluate the efficiency of a new nutraceutical combination based on Berberis, Resveratrol and Astragalus. Subjects: Fifty patients with a first diagnosis of moderate dyslipidemia were included in a 6-week open-label, randomized, parallel-group controlled clinical trial. At study start patients were given dietary counseling and were randomized into two groups treated with either; Combination A(RYR extract containing 10 mg of monacolin k and 160 mg of improved form of highly bioavailable resveratrol (REVIFAST) or Combination B (160mg of REVIFAST, 500 mg of Berberis and 40 mg Astragalus extracts. Results: Compared to baseline values, both treatments reduced significantly total and LDL-cholesterol, systolic blood pressure, and glycemic parameters (Fasting insulinaemia, glucose and HOMA-index). Both combinations reduced total and LDL cholesterol below 5,4mmol/L and 3,12 mg/dL respectively, when compared though, combination B lead to a greater reduction in TC and LDL (p.05) while increased HDL. Fasting insulinaemia and HOMA-index improved both nutraceutical treated groups. Thus, both treatments led to comparable and results in reduced glico-lipidic metabolic parameters with significant differences in further ameliorating lipidic parameters among treated patients with combination B. Conclusions: Treatment with the novel neutraceutical combination based on resveratrol, berberis and Astragalus extracts is superior to combinationcontaining monacolin Kover the 6 week treatment period. Cholesterol, triglycerides and HOMA index had a greater reduction in patients treated with this combination. Both treatments were efficacious, safe, and well tolerated among patients. The absence of monacolin k does not affect the overall efficacy of the novel composition in treatment of dyslipidemia, thus could represent an efficient alternative therapy.