EFFECTIVENESS AND SAFETY OF A NEW GENERATION OF NUTRACEUTICAL COMPOUNDS ON LIPID PROFILE AND SERUM GLYCAEMIA IN SUBJECTS WITH HIGH-NORMAL BLOOD PRESSURE LEVELS

Abstract

Objective: In the 2018 ESH/ESC hypertension guidelines is recommend that patients with high–normal blood pressure (BP) values and low–moderate cardiovascular (CV) risk should be offered lifestyle advice, because this reduces their risk of progressing to established hypertension and may further reduce their CV risk. Treatment strategies include non-pharmacologic interventions and in this respect a relevant role has been shown for nutraceutical compounds (NCs). Design and method: 131 subjects (mean age 55.7 ± 9.6 years, 53% males) with high-normal BP levels (i.e. with systolic BP of 130–139 mmHg and/or with diastolic BP of 85–89 values) without hypertension-mediated organ damage and history of cardio-vascular (CV) diseases were enrolled. 66 subjects were treated with a once-daily oral formulation of a NCs containing red yeast rice (equivalent of 3 mg of Monacolin K), 500 mg of Berberine, 30 mg of Coenzyme Q10, 200 mcg of folic acid and 40 mg of chrome that added to their diet for 3 months and were compared with the 65 patients following a diet program. Differences in serum total cholesterol (TC), low- and high-density-lipo- protein cholesterol (LDLC and HDLC), triglycerides (TG), glucose values, CPK, AST, ALT and BMI were compared by analysis of variance. Results: A significant reduction of TC, LDLC and glucose levels was observed in both treatment groups, while HDLC values significantly increased in the active treatment group (+4.8 %, p < 0.0001). However, a greater reduction of TC (-13.6%) LDLC (-17.7%), and serum glucose (-7.7%) was observed in the treatment group that to the control (p < 0.001 for all). BP, BMI and TG levels remained unchanged (p = N.S.). Gender difference was not found in either group (p = N.S.). No adverse event was observed during the study and safety parameters (i.e AST, ALT and CPK values) was not-different between groups; 2 subjects in the active and 2 in the control group withdrew from the study. Conclusions: In patients with high-normal BP levels, NC supplementation was safe, well tolerated and effective in improving lipid pattern and glucose profile.