The Use of Nigella sativa in Cardiometabolic Diseases.

Nigella sativa L. is an herb that is commonly used in cooking and in traditional medicine, particularly in Arab countries, the Indian subcontinent, and some areas of eastern Europe. Nigella sativa is also called "black cumin" or "black seeds", as the seeds are the most-used part of the plant. They contain the main bioactive component thymoquinone (TQ), which is responsible for the pleiotropic pharmacological properties of the seeds, including anti-oxidant, anti-inflammatory, anti-hypertensive, anti-hepatotoxic, hypoglycemic, and lipid-lowering properties. In this narrative review, both the potential mechanisms of action of Nigella sativa and the fundamental role played by pharmaceutical technology in optimizing preparations based on this herb in terms of yield, quality, and effectiveness have been outlined. Moreover, an analysis of the market of products containing Nigella sativa was carried out based on the current literature with an international perspective, along with a specific focus on Italy.

ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON).

BACKGROUND: Diabetes represents a pro-thrombotic condition. OBJECTIVES: The primary objective was to evaluate the effects of Vitamin K Antagonist (VKA) compared to direct oral anticoagulants (DOACs) in diabetic and nondiabetic patients with non-valvular atrial fibrillation, newly diagnosed. The secondary objective was to evaluate the effects on the risk of bleeding. METHODS: We enrolled 300 patients with newly diagnosed atrial fibrillation. One hundred and sixteen patients were taking warfarin, 31 acenocumarol, 22 dabigatran, 80 rivaroxaban, 34 apixaban, and 17 edoxaban. We evaluated: anthropometric parameters, glycated hemoglobin (HbA1c), fasting and post-prandial glucose (FPG, and PPG), lipid profile, Lp(a), small and dense low-density lipoprotein (SD-LDL), oxidized LDL (Ox-LDL), I-troponin (I-Tn), creatinine, transaminases, iron, red blood cells (RBC); hemoglobin (Hb), platelets (PLT), fibrinogen, D-dimer, anti-thrombin III, C-reactive protein (Hs-CRP), Metalloproteinases-2 (MMP-2), Metalloproteinases-9 (MMP-9), and incidence of bleeding. RESULTS: We did not record any differences among nondiabetic patients between VKA and DOACs. However, when we considered diabetic patients, we found a slight, but significant improvement of triglycerides and SD-LDL. As regards incidence of bleeding, minor bleeding was more frequent in VKA diabetic group compared to DOACs diabetic group; furthermore, the incidence of major bleeding was higher with VKA in nondiabetic and diabetic group, compared to patients with DOACs. Among DOACs, we recorded a higher incidence of bleeding (minor and major) with dabigatran compared to rivaroxaban, apixaban and edoxaban in nondiabetic and diabetic patients. CONCLUSION: DOACs seem to be metabolically favourable in diabetic patients. Regarding incidence of bleeding, DOACs with the exception of dabigatran, seem better than VKA in diabetic patients.

The role of selected nutraceuticals in management of prediabetes and diabetes: An updated review of the literature.

Dysglycemia is a disease state preceding the onset of diabetes and includes impaired fasting glycemia and impaired glucose tolerance. This review aimed to collect and analyze the literature reporting the results of clinical trials evaluating the effects of selected nutraceuticals on glycemia in humans. The results of the analyzed trials, generally, showed the positive effects of the nutraceuticals studied alone or in association with other supplements on fasting plasma glucose and post-prandial plasma glucose as primary outcomes, and their efficacy in improving insulin resistance as a secondary outcome. Some evidences, obtained from clinical trials, suggest a role for some nutraceuticals, and in particular Berberis, Banaba, Curcumin, and Guar gum, in the management of prediabetes and diabetes. However, contradictory results were found on the hypoglycemic effects of Morus, Ilex paraguariensis, Omega-3, Allium cepa, and Trigonella faenum graecum, whereby rigorous long-term clinical trials are needed to confirm these data. More studies are also needed for Eugenia jambolana, as well as for Ascophyllum nodosum and Fucus vesiculosus which glucose-lowering effects were observed when administered in combination, but not alone. Further trials are also needed for quercetin.

Evaluation of the Effect on Sexual Performance of a Nutraceutical Combination Containing Alpha Lipoic Acid, Vitis vinifera L. and Ginkgo biloba, Compared to Placebo, Avanafil or a Combination of Nutraceutical Plus Avanafil in Males With Type 2 Diabetes Mellitus With Erectile Dysfunction.

Aim: To evaluate if therapy with a nutraceutical combination of alpha lipoic acid, Vitis vinifera L. and Ginkgo biloba (Blunorm forte®) can be helpful and be synergic with Avanafil. Methods: The trial included 123 males with type 2 diabetic mellitus and with erectile dysfunction (ED), aged ≥18 years. Patients were divided in four different arms: 1st arm: placebo during the three months of treatment and before sexual act; 2nd arm: placebo for three months and Avanafil: 1 tablet, 200 mg, 15-30 minutes before sexual act; 3rd arm: Blunorm forte: 1 tablet, 40 minutes before the meal (breakfast) during the three months and Avanafil: 1 tablet, 200 mg, 15-30 minutes before sexual act; 4th arm: Blunorm forte: 1 tablet, 40 minutes before the meal (breakfast and dinner) during the three months and placebo 15-30 minutes before sexual act. Results: A significant reduction of fasting plasma glucose, and homeostasis model assessment-insulin resistance index were recorded both in Avanafil + Blunorm forte and with Blunorm forte. Metalloproteinases-2, and -9 were reduced in the Avanafil + Blunorm forte group. High sensitivity-C-reactive protein was decreased by both Avanafil, and Avanafil + Blunorm forte group. No variations were recorded with the other treatments. The group treated with Blunorm forte and Avanafil reached a higher International Index of Erectile Function (IIEF) score after 3 months of therapy compared to baseline and placebo and compared to Avanafil and Blunorm forte taken alone. Conclusion: Blunorm forte® can be helpful and synergic with Avanafil in increasing sexual performance compared to placebo.

Vitamin D3 supplementation improves glycemic control in type 2 diabetic patients: Results from an Italian clinical trial.

Background: to evaluate the effects of Vitamin D3 on glyco-metabolic control in type 2 diabetic patients with Vitamin D deficiency. Methods: one hundred and seventeen patients were randomized to placebo and 122 patients to Vitamin D3. We evaluated anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value at baseline, after 3, and 6 months. Results: a significant reduction of fasting, and post-prandial glucose was recorded in Vitamin D3 group after 6 months. A significant HbA1c decrease was observed in Vitamin D3 (from 7.6% or 60 mmol/mol to 7.1% or 54 mmol) at 6 months compared to baseline, and to placebo (p < 0.05 for both). At the end of the study period, we noticed a change in the amount in doses of oral or subcutaneous hypoglycemic agents and insulin, respectively. The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group. The units of Lispro, Aspart, and Glargine insulin were lower in the Vitamin D3 group at the end of the study (p = 0.031, p = 0.037, and p = 0.035, respectively) than in the placebo group. Conclusions: in type 2 diabetic patients with Vitamin D deficiency, the restoration of value in the Vitamin D standard has led not only to an improvement in the glyco-metabolic compensation, but also to a reduced posology of some oral hypoglycemic agents and some types of insulin used.

Metabolic Actions of a Supplement of Ilex Paraguariensis (An Extract of the Leaf Standardized to 2% I-Deoxinojirimcina), White Mulberry and Chromium Picolinate in Nondiabetic Subects with Dysglycemia: A Randomized Trial.

AIM: To prove if a nutraceutical containing Ilex paraguariensis (Ilex L. spp. Aquifoliales) (an extract of the leaf standardized to 2% I-deoxinojirimcina), white mulberry (Morus spp., Moraceae), and chromium picolinate can be effective in improving glycemic status in subject with dysglycemia. METHODS: We randomized patients to consume placebo or the nutraceutical, self-administered once a day, one tablet at breakfast, for 3 months. RESULTS: A reduction in fasting plasma glucose, postprandial glucose, and glycated hemoglobin was observed with the nutraceutical combination, both compared to baseline and placebo. Data suggested a decrease in the Homeostasis Model Assessment index with the nutraceutical, both compared to baseline and placebo. The M value, an index of insulin sensitivity, obtained after nutraceutical treatment was higher compared to baseline. We recorded a decrease in total cholesterol, low-density lipoprotein-cholesterol, and triglycerides with the nutraceutical combination compared to baseline and placebo. A decrease in high-sensitivity C-reactive protein was observed with the nutraceutical combination compared to baseline and placebo. CONCLUSIONS: A nutraceutical containing Ilex paraguariensis, white mulberry, and chromium picolinate can be helpful in improving glycemic status and lipid profile in dysglycemic subjects.

Nutraceutical Approach to Preventing Coronavirus Disease 2019 and Related Complications.

Introduction: Several months ago, Chinese authorities identified an atypical pneumonia in Wuhan city, province of Hubei (China) caused by a novel coronavirus (2019-nCoV or SARS-CoV-2). The WHO announced this new disease was to be known as "COVID-19". Evidence Acquisition: Several approaches are currently underway for the treatment of this disease, but a specific cure remains to be established. Evidence Synthesis: This review will describe how the use of selected nutraceuticals could be helpful, in addition to pharmacological therapy, in preventing some COVID-19-related complications in infected patients. Conclusions: Even if a specific and effective cure for COVID-19 still has some way to go, selected nutraceuticals could be helpful, in addition to pharmacological therapy, in preventing some COVID-19-related complications in infected patients.

A role for quercetin in coronavirus disease 2019 (COVID-19).

Several months ago, an outbreak of pneumonia of unknown aetiology was detected in Wuhan City (China) and the aetiological agent of the atypical pneumonia was isolated by the Chinese authorities as novel coronavirus (2019-nCoV or SARS-CoV-2). The WHO announced this new disease was to be known as "COVID-19." When looking for new antiviral compounds, knowledge of the main viral proteins is fundamental. The major druggable targets of SARS-CoV-2 include 3-chymotrypsin-like protease (3CLpro), papain-like protease (PLpro), RNA-dependent RNA polymerase, and spike (S) protein. Quercetin inhibits 3CLpro and PLpro with a docking binding energy corresponding to -6.25 and -4.62 kcal/mol, respectively. Quercetin has a theoretical, but significant, capability to interfere with SARS-CoV-2 replication, with the results showing this to be the fifth best compound out of 18 candidates. On the basis of the clinical COVID-19 manifestations, the multifaceted aspect of quercetin as both antiinflammatory and thrombin-inhibitory actions, should be taken into consideration.

Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention.

AIM: To evaluate the safety of four different dosages of alpha lipoic acid (400, 600, 800, and 1200 mg) as food supplement on adverse events related to alpha lipoic acid consumption and efficacy on glycemic status and lipid profile in subjects with euglycemia or dysglycemia. METHODS: We conducted a retrospective, observational study enrolling 322 patients, 83 taking 400 mg/day, 78 taking 600 mg/day, 80 taking 800 mg/day, and 81 taking 1200 mg/day alpha lipoic acid, respectively. RESULTS: In the groups treated with alpha lipoic acid 800 and 1200 mg/day, we registered a reduction of FPG, TC, LDL-C, and Tg compared to baseline (p < 0.05 for all with alpha lipoic acid 800 mg/day, and p < 0.01 for all with alpha lipoic acid 1200 mg/day). The values recorded in the group treated with alpha lipoic acid 1200 mg/day were significantly lower compared to the ones obtained with alpha lipoic acid 400 mg/day. Moreover, alpha lipoic acid 1200 mg/day reduced Hs-CRP levels compared to baseline and compared to 400 mg/day (p < 0.05 for both). In the group treated with alpha lipoic acid at 800 mg/day, 5 subjects with IFG and 1 subject with IGT returned euglycemic. In the group treated with alpha lipoic acid at 1200 mg/day, 11 subjects with IFG and 3 subjects with IGT returned euglycemic. Adverse events of patients during alpha lipoic acid treatment included nausea, vomiting, dizziness, cutaneous rash, hypoglycemia, and hypotension. Adverse events did not differ among the four groups. CONCLUSION: The chronic use (4 years) of a food supplement containing alpha lipoic acid is well tolerated, without significant differences between lower and higher dosages and improves glycemic status and lipid profile but only if administered at high dosage.

Abscisic Acid Treatment in Patients with Prediabetes.

AIM: to evaluate the effects of abscisic acid (ABA), contained in dwarf peaches, on the regression of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) conditions. MATERIALS AND METHODS: sixty-five patients with IFG or IGT were randomized to take ABA or placebo for 3 months. We evaluated: fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA1c), fasting plasma insulin (FPI), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile and high sensitivity C-reactive protein (Hs-CRP). At baseline, and after 3 months, all patients underwent an oral glucose tolerance test (OGTT), an euglycemic hyperinsulinemic clamp, and a glucagon test. RESULTS: a significant reduction of HbA1c, FPG, PPG, FPI and HOMA-IR was observed in the ABA group. After 3 months, 26.7% of patients returned to a normal glycemic status in the ABA group versus zero patients in placebo group; 20.0% were classified as IFG and 53.3% as IGT in the nutraceutical group versus 33.3% and 63.3% in the placebo group. The M value was higher in the ABA group at the end of the treatment. Finally, Hs-CRP was reduced after 3 months of ABA consumption. CONCLUSIONS: abscisic acid can be effective in ameliorating glyco-metabolic compensation and in reducing inflammatory status in patients with IFG or IGT.

Lipid-lowering nutraceuticals update on scientific evidence.

: Cardiovascular diseases (CVDs) are the main cause of mortality worldwide. Risk factors of CVD can be classified into modifiable (smoking, hypertension, diabetes, hypercholesterolemia) through lifestyle changes or taking drug therapy and not modifiable (age, ethnicity, sex and family history). Elevated total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) levels have a lead role in the development of coronary heart disease (CHD), while high levels of high-density lipoprotein-cholesterol (HDL-C) seem to have a protective role.The current treatment for dyslipidemia consists of lifestyle modification or drug therapy even if not pharmacological treatment should be always considered in addition to lipid-lowering medications.The use of lipid-lowering nutraceuticals alone or in association with drug therapy may be considered when the atherogenic cholesterol goal was not achieved.These substances can be classified according to their mechanisms of action into natural inhibitors of intestinal cholesterol absorption, inhibitors of hepatic cholesterol synthesis and enhancers of the excretion of LDL-C. Nevertheless, many of them are characterized by mixed or unclear mechanisms of action.The use of these nutraceuticals is suggested in individuals with borderline lipid profile levels or with drug intolerance, but cannot replace standard lipid-lowering treatment in patients at high, or very high CVD risk.Nutraceuticals can also have vascular effects, including improvement in endothelial dysfunction and arterial stiffness, as well as antioxidative properties. Moreover, epidemiological and clinical studies reported that in patients intolerant of statins, many nutraceuticals with demonstrated hypolipidemic effect are well tolerated.

Change of some oxidative stress parameters after supplementation with whey protein isolate in patients with type 2 diabetes.

OBJECTIVES: The aim of this study was to evaluate the effects of undenatured whey protein isolate (WPI; ≥92.5%) with a high content of native cysteine (2.7%) and a standardized content of lactoferrin (≥0.7%) on parameters related to oxidative stress and inflammation in individuals with type 2 diabetes mellitus. METHODS: We assigned 120 white patients with type 2 diabetes and glycated hemoglobin ≥6.5% to two groups. The patients were supplemented daily with WPI or placebo for 3 mo. After 3 mo, the markers of oxidation (superoxide dismutase, glutathione peroxidase, glutathione, and reduced glutathione-to-oxidized glutathione ratio) and inflammation (high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor -α, malondialdehyde) were significantly lower in the WPI group than in the placebo group (P < 0.05). The WPI group obtained a significant improvement in the lipid profile and a reduction in fasting plasma glucose compared with baseline and placebo (P < 0.05). No variations of body weight, body mass index or circumferences and metalloproteinase-2 and -9, or soluble receptor for advanced glycation end product were recorded in either groups. CONCLUSION: Supplementation with WPI may be useful in patients with diabetes to control fasting glycemia. Moreover, it can help to improve inflammatory and oxidative stress, which play a crucial role in the development of diabetes complications and also in the progression of other chronic diseases.

Ilex paraguariensis, white mulberry and chromium picolinate in patients with pre-diabetes.

AIM: to evaluate if a nutraceutical compound containing Ilex paraguariensis, White Mulberry and Chromium Picolinate can ameliorate glycemic status in patients with pre-diabetes. METHODS: we enrolled patients with IFG or IGT, not taking other hypoglycemic compounds. Patients were randomized to take placebo or the nutraceutical compound for 3 months, in a randomized, double-blind, placebo-controlled design. Both treatments were self-administered once a day, 1 tablet during the breakfast. RESULTS: a reduction of FPG was observed with the nutraceutical combination (-7.8%). Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%). M value was higher (p < 0.05 vs baseline and p < 0.05 vs placebo) at the end of the treatment. We obtained a reduction of Tg with the nutraceutical combination (-8.3%). About 16.6% of patients treated with nutraceutical returned to have a normal glycemia (< 100 mg/dL), and all patients had an improvement of insulin-resistance, in particular 67% of patients returned to have a M value inside range of normal insulin sensitivity. CONCLUSIONS: a nutraceutical containing Ilex paraguariensis, White Mulberry and Chromium Picolinate at 500 mg can be helpful in improving glycemia and Tg value, in patients with pre-diabetes.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effectiveness of a Food Supplement Containing Creatine and D-Ribose Combined with a Physical Exercise Program in Increasing Stress Tolerance in Patients with Ischemic Heart Disease.

The aim of this study is to establish whether a supplement of creatine and ribose combined with a physical exercise program can improve the total work capacity during exercise in a population of patients with known ischemic heart disease. A double-blind, six-month study was designed in which 53 patients were enrolled and randomized to take either a nutraceutical composition containing creatine, D-ribose, vitamin B1, and vitamin B6 (active treatment) or the placebo. Both the nutraceutical supplement and the placebo were supplied by Giellepi S.p.A. Health Science in Lissone, Italy. After six months of study, the cardiac double product at the peak of the load, the delta double product, and the chronotropic index were higher in the active treatment group than in the placebo group. We can conclude that a supplementation with creatine, D-ribose, vitamin B1, and vitamin B6, in addition to standard therapy and a physical exercise program, seems to be helpful in improving exercise tolerance compared to the placebo in a population with cardiovascular disease. However, this needs to be further studied, given that there is no clear evidence that the double product can be used as a surrogate measure of exercise tolerance.

Coenzyme q10 liquid supplementation in dyslipidemic subjects with statin-related clinical symptoms: a double-blind, randomized, placebo-controlled study.

INTRODUCTION: Statin-associated myalgia occurs in about 1-3% of patients in the medical literature. Plasma CoQ10 levels are reduced in patients undergoing statin. OBJECTIVE: The primary outcome was the detection of clinical symptoms and the perception of pain evaluated throughout specific questionnaires. The secondary outcome was the variation in lipid profile and the variation in safety parameters. METHODS: We enrolled 60 Caucasian patients, intolerant to statins. During the run-in period, patients underwent a 1-month wash-out period during which statins were stopped. At the end of the wash-out period, if CPK and/or transaminases returned within an acceptable range, statins were re-introduced at half of the previously taken dose. After one month, patients were randomized to take either a liquid CoQ10 supplement or a placebo for three months at 100 mg/day. RESULTS: The Clinical Index Score for myalgia assessment was lower after 3 months with CoQ10, while it did not change with the placebo. The VAS score was lower after 3 months of CoQ10 supplementation, while no variation was recorded with the placebo. In the group treated with the dietary supplement, CoQ10 plasma concentrations were inversely correlated with CPK levels, Clinical Index Score absolute values, and VAS. CONCLUSION: The addition of CoQ10 with half dosage statin in patients with previous intolerance to statins improves the perception of clinical symptoms such as asthenia, myalgia or pain.

Ascophyllum nodosum and Fucus vesiculosus on glycemic status and on endothelial damage markers in dysglicemic patients.

The aim of this study was to evaluate a nutraceutical combination containing polyphenols extracted from Ascophyllum nodosum and Fucus vesiculosus and chromium picolinate on glyemic status; secondary outcomes were considered the changes on endothelial markers. We randomized 65 dysglycemic patients to placebo or the nutraceutical agent for 6 months. We evaluated fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c , fasting plasma insulin, homeostatic model assessment (HOMA) index, high sensitivity C-reactive protein (Hs-CRP), tumor necrosis factor-α (TNF-α), and adhesion molecules. At baseline and at 3 and 6 months, all patients underwent an oral glucose tolerance test. We recorded a reduction of HbA1c , FPG, PPG, and HOMA-IR compared with placebo (p < 0.05). After 6 months, 18.2% of patients retuned to a normal glycemic status in the nutraceutical group versus 0 patients in placebo group (p < 0.05); 69.7% were classified as impaired fasting glycemia and 12.1% as impaired glucose tolerance in the nutraceutical group versus 17.2% and 82.8 in placebo group (p < 0.01) for both. A reduction of Hs-CRP and TNF-α was recorded with the nutraceutical. The administration of a nutraceutical combination containing A. nodosum and F. vesiculosus can be helpful in improving insulin sensitivity and glycemic status. Larger randomized studies are required to confirm the positive effects of these agents.

Effects on oral fat load of a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols: A randomized, placebo controlled trial.

BACKGROUND: In literature, there are several studies about the effects of nutraceutical combinations at fasting, but data in post-prandial phase are lacking. PURPOSE: We planned a study to evaluate the efficacy and safety of a nutraceutical agent containing fermented red rice, phytosterols and olive polyphenols compared to placebo in a sample of Caucasian patients with low cardiovascular risk, both at fasting and after an oral fat load. STUDY DESIGN: Eighty patients were randomized to receive, as addition to diet and physical activity, a nutraceutical combination containing fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols or placebo (control group), once a day. METHODS: We evaluated at baseline, and after 3 months: body mass index, fasting plasma glucose, lipid profile, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and soluble endothelial-leukocyte adhesion molecule-1. We evaluated these parameters both at fasting, and after an oral fat load. RESULTS: Nutraceutical combination gave a reduction of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). We recorded a reduction of soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and sE-selectin in the group treated with nutraceutical combination, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). Parameters recorded during oral fat load improved compared to the oral fat load performed at baseline with the nutraceutical combination. CONCLUSIONS: The nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols seems to be effective in improving lipid profile and markers of endothelial damage in dyslipidemic patients in primary prevention at low risk for developing cardiovascular disease. The true novelty of this study, however, is the improvement of endothelial damage after an oral fat load compared to placebo.

Effects of a Combination of Berberis aristata, Silybum marianum and Monacolin on Lipid Profile in Subjects at Low Cardiovascular Risk; A Double-Blind, Randomized, Placebo-Controlled Trial.

The aim of this study was to evaluate the efficacy and safety of an anti-hypercholesterolemic agent containing Berberis aristata, Silybum marianum and monacolin K and KA in a sample of Caucasian patients at low cardiovascular risk according to Framingham score. The primary outcome was to evaluate the effects of this nutraceutical combination on lipid profile; the secondary outcome was to evaluate the effect on some inflammatory markers, in particular high sensitivity C-reactive protein and tumor necrosis factor-α interleukin-6. One hundred and forty-three patients were randomized to placebo or Berberol® K, once a day, during the dinner, for 3 months, in a randomized, double-blind, placebo-controlled trial. We recorded a significant reduction of fasting plasma glucose with Berberol® K compared to placebo (-12.2%, p < 0.05). Moreover, we recorded an increase of fasting plasma insulin with Berberol® K both compared to baseline and to placebo (+9.9%, p < 0.05). Accordingly, the homeostasis model assessment (HOMA) index obtained after treatment with Berberol® K was lower than the one in the placebo group (-2.8%, p < 0.05). No variations of lipid profile were observed with placebo, while there was a significant decrease of total cholesterol (-20.5%, p < 0.05), triglycerides (-17.7%, p < 0.05), and low density lipoprotein (LDL) cholestero (-27.8%, p < 0.05) with Berberol® K, compared to placebo. There was a decrease of high sensitivity C-reactive protein (-30.8%, p < 0.05), and interleukin-6 (-25.0%, p < 0.05), with Berberol® K compared to placebo. In conclusion, combining different hypocholesterolemic nutraceutical agents such as Berberis aristata, Silybum marianum and monacolin K and KA could be effective and safe to obtain a reduction of lipid profile and an improvement of inflammatory parameters.

A Clinical Trial about a Food Supplement Containing α-Lipoic Acid on Oxidative Stress Markers in Type 2 Diabetic Patients.

The aim of this study was to evaluate the effect of a food supplement containing α-lipoic acid and of a placebo on glyco-metabolic control and on oxidative stress markers in type 2 diabetics. We randomized 105 diabetics to either a supplementation containing 600 mg of α-lipoic acid, 165 mg of L-carnosin, 7.5 mg of zinc, and vitamins of group B, or a placebo, for three months. We evaluated body mass index, fasting plasma glucose (FPG), post-prandial-glucose (PPG), glycated hemoglobin (HbA1c), fasting plasma insulin (FPI), HOMA-index (HOMA-IR), lipid profile, high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA). There was a reduction of FPG, PPG, and HbA1c with the food supplement containing α-lipoic acid compared with a baseline, and with the placebo. Concerning lipid profile, we observed a reduction of LDL-C, and Tg with the food supplement, compared with both the baseline, and the placebo. There was a reduction of Hs-CRP with the food supplement containing α-lipoic acid, both compared with the baseline and the placebo. An increase of SOD, and GSH-Px, and a decrease of MDA were reached by the food supplement containing α-lipoic acid, both compared with the baseline and the placebo. We can conclude that the food supplement containing α-lipoic acid, L-carnosin, zinc, and vitamins of group B improved glycemic control, lipid profile, and anti-oxidative stress markers.

Barnidipine compared to lercanidipine in addition to losartan on endothelial damage and oxidative stress parameters in patients with hypertension and type 2 diabetes mellitus.

BACKGROUND: Essential hypertension has been extensively reported to cause endothelial dysfunction. The aim of this study was to evaluate the effects of barnidipine or lercanidipine, in addition to losartan, on some parameters indicative of endothelial damage and oxidative stress in hypertensive, type 2 diabetic patients. METHODS: One hundred and fifty one patients were randomised to barnidipine, 20 mg/day, or lercanidipine, 20 mg/day, both in addition to losartan, 100 mg/day, for 6 months. We assessed BP every month, in addition, patients underwent ambulatory blood pressure monitoring (ABPM). We also assessed: fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), some markers such as high-sensitivity C-reactive protein (Hs-CRP), tumor necrosis factor-α (TNF-α), metalloproteinase-2 (MMP-2) and -9 (MMP-9), soluble vascular adhesion protein-1 (sVCAM-1), soluble intercellular adhesion protein-1 (sICAM-1), isoprostanes and paraoxonase-1 (PON-1). RESULTS: Both barnidipine and lercanidipine resulted in a significant reduction in blood pressure, even if the reduction obtained with barnidipine + losartan was greater than that obtained with lercanidipine + losartan. Data recorded with ABPM also showed a similar trend. Barnidipine + losartan reduced the levels of Hs-CRP, TNF-α, sVCAM-1, sICAM-1, and isoprostanes both compared to baseline and to lercanidipine + losartan. CONCLUSIONS: Barnidipine + losartan gave an improvement of some parameters indicative of endothelial damage and oxidative stress in diabetic and hypertensive patients. TRIAL REGISTRATION: NCT02064218 , ClinicalTrials.gov.