Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients.

BACKGROUND: Relatively large number of dietary supplements and nutraceuticals have been studied for their supposed or demonstrated ability to reduce cholesterolemia in humans. OBJECTIVES: The aim of this study was to evaluate the efficacy as antihypercholesterolemic and insulin-sensitizing agent of a combination of Berberis aristata/Silybum marianum extract (Berberol®) in a sample of dyslipidemic patients. A total of 102 dyslipidemic subjects were enrolled. After a 6 months run-in period of diet and physical activity, the patients were randomized to placebo or Berberis aristata/Silybum marianum extract 588 mg/105 mg, twice a day for 3 months. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (washout period), and then restarted for further 3 months. Anthropometric and metabolic parameters were assessed; moreover, all patients underwent a glucagon stimulation test. RESULTS: Berberis aristata/Silybum marianum reduced total cholesterol, triglycerides and low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol after 3 months from randomization and compared to placebo group. When Berberis aristata/Silybum marianum was interrupted, lipid profile worsened, and it improved again when nutraceutical combination was reintroduced. During the glucagon stimulation test, a higher increase of C-peptide levels and a lower increase in glycemia after the test with Berberis aristata/Silybum marianum compared to placebo, to baseline and to randomization were recorded. No patients had serious adverse events in both groups. CONCLUSION: Berberis aristata/Silybum marianum is effective and safe in improving lipid profile and insulin secretion in euglycemic dyslipidemic patients.

Effects of berberine on lipid profile in subjects with low cardiovascular risk.

OBJECTIVE: To evaluate the efficacy as antihypercholesterolemic agent of berberine in patients with low cardiovascular risk. RESEARCH DESIGN AND METHODS: 144 Caucasian subjects were enrolled. After a 6-month run-in period following diet and practicing physical activity, patients were randomized to take placebo or berberine 500 mg twice a day, for 3 months, in a double-blind, placebo-controlled design. Berberine and placebo were then interrupted for 2 months (washout period), and all patients continued with only diet and physical activity. At the end of the washout period, patients restarted berberine or placebo twice a day for further 3 months. Anthropometric and metabolic parameters were assessed during the run-in period, at randomization, before and after the washout period. RESULTS: A decrease of body weight and BMI was observed after the run-in period. Berberine reduced total cholesterol, triglycerides and LDL cholesterol and increased HDL cholesterol after 3 months from randomization and compared with placebo. After the washout period, lipid profile worsened; afterward, when berberine was reintroduced, lipid profile improved again both compared with the washout period, and with placebo. CONCLUSIONS: Berberine is effective and safe to mildly improve lipid profile in subjects with low risk for cardiovascular disease.

Effects of n-3 PUFAs on postprandial variation of metalloproteinases, and inflammatory and insulin resistance parameters in dyslipidemic patients: evaluation with euglycemic clamp and oral fat load.

BACKGROUND: The oral fat load (OFL) is considered as one of the most accurate models of postprandial lipoprotein metabolism and it has been widely used to evaluate the postprandial fat load effect on single markers of inflammation. OBJECTIVE: To evaluate the effects of n-3 PUFAs, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with a content of 400 mg of EPA and 450 mg of DHA in each capsule, on metalloproteinases and inflammatory biomarkers in patients affected by combined dyslipidemia both in a fasting state and after a standardized OFL in a randomized, placebo-controlled trial. METHODS: Placebo or n-3 PUFAs 3 g/day (1 g three times a day during the meals) was administered for 6 months. At the baseline, and after 2, 4, and 6 months we evaluated body mass index (BMI), body weight, fasting plasma glucose (FPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), blood pressure, lipid profile, soluble intercellular adhesion molecule-1 (sICAM-1), interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), sE-selectin, tumor necrosis factor-α (TNF-α), and metalloproteinases 2 and 9 (MMP-2 and 9). Furthermore, at the baseline and at the end of the study, all patients underwent an euglycemic hyperinsulinemic clamp and an oral fat load. RESULTS: Tg levels were lower (-54 mg/dL) and high-density lipoprotein cholesterol higher (+6 mg/dL) with n-3 PUFAs compared with placebo; n-3 PUFAs gave lower levels of FPG (-3 mg/dL), sICAM (-25 ng/mL), IL-6 (-0.3 pg/mL), hs-CRP (-0.6 mg/L), sVCAM-1 (-89 ng/mL), sE-selectin (-5.8 ng/mL), TNF-α (-0.3 ng/mL), MMP-2 (-185.1 ng/mL), and MMP-9 (-91.5 ng/mL), and a greater M value (+1.21 µmol/min/kg) compared with placebo. After the OFL, there was a decrease of Tg, MMPs, and all inflammatory parameters with n-3 PUFAs, but not with placebo. CONCLUSION: Supplementation with n-3 PUFA resulted in lower levels of FPG, plasma lipids, MMPs, and inflammatory parameters and in a better increase of M value compared to placebo, both in the fasting state and after an OFL.