Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease. Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients Eulipidemic effects of berberine administered alone or in combination with other natural cholesterol-lowering agents. A single-blind clinical investigation. Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols, and Berberine) in Patients with Low-Moderate Risk Hypercholesterolemia: A Double-Blind, Placebo-Controlled Study Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Effects of Poly-Bioactive Compounds on Lipid Profile and Body Weight in a Moderately Hypercholesterolemic Population with Low Cardiovascular Disease Risk: A Multicenter Randomized Trial Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial NUtraceutical TReatment for hYpercholesterolemia in HIV-infected patients: The NU-TRY(HIV) randomized cross-over trial. Effects of carnitine and coenzyme Q10 on lipid profile and serum levels of lipoprotein(a) in maintenance hemodialysis patients on statin therapy. Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance. Treatment of type 2 diabetes and dyslipidemia with the natural plant alkaloid berberine. Effect of Red Yeast Rice and Coconut, Rice Bran or Sunflower Oil Combination in Rats on Hypercholesterolemic Diet. Combined nutraceutical approach to postmenopausal syndrome and vascular remodeling biomarkers. Effect of liquid ubiquinol supplementation on glucose, lipids and antioxidant capacity in type 2 diabetes patients: a double-blind, randomised, placebo-controlled trial. Relationship between Adiponectin and Leptin, and Blood Lipids in Hyperlipidemia Patients Treated with Red Yeast Rice Effects of metformin plus gliclazide versus metformin plus glimepiride on cardiovascular risk factors in patients with type 2 diabetes mellitus. Canadian Cardiovascular Society position statement--recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial Effect of postprandial hypertriglyceridemia and hyperglycemia on circulating adhesion molecules and oxidative stress generation and the possible role of simvastatin treatment. Stabilization of homocysteine in unseparated blood over several days: a solution for epidemiological studies. Effect of combined coenzyme Q10 and d-alpha-tocopheryl acetate supplementation on exercise-induced lipid peroxidation and muscular damage: a placebo-controlled double-blind study in marathon runners. Plasma ubiquinone status and response to six-month supplementation combined with multivitamins in healthy elderly women--results of a randomized, double-blind, placebo-controlled study.
Statins are extensively used to treat dyslipidemia , but , because of their low tolerability profile , they are discontinued in a significant proportion of patients . Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated . A single-blind , single-center , r and omized , prospect i ve , and parallel group trial comparing a combination of nutraceuticals ( red yeast rice , policosanol , berberine , folic acid , coenzyme Q10 and astaxanthin ) , called Armolipid Plus , and ezetimibe for 3 months in terms of efficacy and tolerability . Patients who did not achieve their therapeutic target ( low-density lipoprotein cholesterol < 100 mg/dl ) could add the alternative treatment on top of r and omized treatment for another 12 months : 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled ( ezetimibe n = 50 , nutraceutical n = 50 ) . Efficacy ( lipid profile ) and tolerability ( adverse events , transaminases , and creatine kinase ) were assessed after 3 and 12 months . After 3 months , 14 patients in the nutraceutical group achieved their therapeutic target , whereas none of the patients in the ezetimibe group did . At 1-year follow-up , 58 patients ( 72.5 % ) of the combined therapy group ( n = 86 ) and 14 ( 100 % ) of the nutraceutical group reached the therapeutic goal . No patients experienced important undesirable effects . In conclusion , nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease . Further studies are needed to assess long-term effects of nutraceuticals on mortality Introduction Statins are at the forefront of strategies to manage dyslipidemia , although they are not always well tolerated . At 6–7 months after the drug was supplied , discontinuation rates averaged 30 % . Alternate agents to statins have been studied . Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations . However , there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients . The purpose of this study was to examine the efficacy , safety , and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins . Methods This study was performed as a r and omized , prospect i ve , parallel group , single-blind study . Patients were included in the study if they had high total cholesterolemia , high low-density lipoprotein cholesterol ( LDL-C ) , > 75 years of age , statin-intolerant , and were refusing other pharmaceutical treatments for hypercholesterolemia . At the baseline visit , eligible patients were r and omized to either nutraceutical-combined pill ( containing berberine 500 mg , policosanol 10 mg , red yeast rice 200 mg , folic acid 0.2 mg , coenzyme Q10 2.0 mg , and astaxanthin 0.5 mg ) or placebo , and the first dose was dispensed . The efficacy , safety , and tolerability of the proposed treatment were fully assessed after 3 , 6 , and 12 months of treatment . Results Out of 106 consecutive patients screened , 80 eligible patients were r and omized to receive either nutraceutical-combined pill ( 40 patients ) or placebo ( 40 patients ) . No patients were lost and no deaths occurred during the follow-up . There was a statistically significant reduction in total cholesterolemia ( −20 % ) , LDL-C ( −31 % ) , and insulin resistance ( −10 % ) with nutraceutical treatment . No significant changes were detected for plasma high-density lipoprotein cholesterol ( HDL-C ) . Furthermore , no statistical differences were found between baseline and end- study safety parameters . Medication compliance and tolerability were high . Conclusion In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant .  Combined nutraceuticals is also safe and well tolerated in these patients Berberine ( BERB ) and a combination ( COMB ) of berberine ( CAS 2086 - 83 - 1 ) with policosanol ( CAS 557 - 61 - 9 ) , red yeast extract ( containing monacolin , CAS 557 - 61 - 9 ) , folic acid and astaxanthin were orally administered daily for 4 weeks to 40 subjects with moderate dyslipidemias divided in two parallel groups each of 20 subjects .  Total cholesterol ( TC ) , LDL , HDL , Non HDL , ApoB , ApoA , Lp(a ) and triglycerides ( TG ) were measured before and at the end of treatments . BERB and COMB significantly reduced TC ( respectively by 16 % and 20 % ) , LDL ( by 20 % and 25 % ) , ApoB ( by 15 % and 29 % ) and TG ( by 22 % and 26 % ) , and increased HDL ( by 6.6 % and 5.1 % ) . Adverse events or impairments of liver transaminases or of CPK were not observed . In conclusion , food supplements containing natural products such as berberine , policosanol , red yeast extracts , folic acid and astaxanthin could be a useful support to diet and life style changes to correct dyslipidemias and to reduce cardiovascular risk in subjects with moderate mixed dyslipidemias Background Statins are at the forefront of strategies to manage hypercholesterolemia . However 10 % to 15 % of patients are intolerant to any statin drugs , even at low daily doses and almost one-third of statin users discontinue therapy within 1 year . Some nutraceuticals are prescribed as lipid-lowering substances , but doubts remain about their efficacy and tolerability . Objectives We aim ed to investigate the efficacy and the safety of a nutraceutical combination consisting mainly of 200 mg red yeast rice extract ( equivalent to 3 mg monacolins ) , 500 mg berberine , and 10 mg policosanols ( MBP-NC ) in patients with low-moderate risk hypercholesterolemia . Methods In this single centre , r and omized , double-blind , placebo-controlled study 60 consecutive out patients ( 29 men and 31 women ; age range = 18–60 years ) , with newly diagnosed primary hypercholesterolemia not previously treated , after a run-in period of 3 weeks on a stable hypolipidic diet , were r and omized to receive a pill of MBP-NC ( n = 30 ) or placebo ( n = 30 ) once a day after dinner , in addition to the hypolipidic diet . The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4 , 12 , and 24 weeks of treatment . Results In the MBP-NC group both total cholesterol and LDL-C already showed a significant reduction at Week 4 ( –30.3 % ± 33.9 % and –29.4 % ± 35.3 % , respectively ) that remained substantially unchanged at Week 12 ( –26.7 % ± 33.1 % and –25.6 % ± 31.5 % , respectively ) and at Week 24 ( –24.6 % ± 32.1 % and –23.7 % ± 32.6 % , respectively ) . The between-groups differences were significant at all time points for both total cholesterol and LDL-C. There were no significant changes in HDL-C , fasting glucose , and triglyceride serum levels in either group . MBP-NC  was also safe and well tolerated . Conclusions In patients with low- to moderate-risk hypercholesterolemia  a nutraceutical combination in association with a hypolipidic diet  significantly reduced total cholesterol and LDL-C levels and may favor the reaching the recommended cholesterol targets . Clinical Trials.gov identifier : NCT02078167 BACKGROUND AND AIMS Some nutraceuticals are prescribed as lipid-lowering substances . However , doubts remain about their efficacy . We evaluated the effects of a nutraceutical combination ( NC ) , consisting of 500 mg berberine , 200 mg red yeast rice and 10 mg policosanols , on cholesterol levels and endothelial function in patients with hypercholesterolemia . METHODS AND RESULTS In this single centre , r and omized , double-blind , placebo-controlled study , 50 hypercholesterolemic patients ( 26 males and 24 females , mean age 55±7 years , total cholesterol 6.55±0.75 mmol/l , BMI 28±3.5 ) were r and omized to 6 weeks of treatment with a daily oral dose of NC  ( 25 patients ) or placebo  ( 25 patients ) . In a subsequent open-label extension of 4 weeks , the whole sample received NC . The main outcome measure was decrease total cholesterol ( C ) levels in the NC arm . Secondary outcome measures were decreased low-density lipoprotein cholesterol ( LDL-C ) and triglyceride levels , and improved endothelial-dependent flow-mediated dilation ( FMD ) and insulin sensitivity in relation to NC . Evaluation of absolute changes from baseline showed significant reductions in NC versus placebo for C and LDL-C ( C : -1.14±0.88 and -0.03±0.78 mmol/l , p<0.001 ; LDL-C : -1.06±0.75 and -00.4±0.54 mmol/l , p<0.001 ) , and a significant improvement of FMD ( 3±4 % and 0±3 % respectively , p<0.05 ) . After the extension phase , triglyceride levels decreased significantly from 1.57±0.77 to 1.26±0.63 mmol/l , p<0.05 and insulin sensitivity improved in a patient subgroup with insulin resistance at baseline ( HOMA : from 3.3±0.4 to 2.5±1.3 , p<0.05 ) . No adverse effect was reported . CONCLUSIONS This NC reduces cholesterol levels . The reduction is associated with improved endothelial function and insulin sensitivity A dietary supplement ( AP , Armolipid Plus ) that combines red yeast rice extract , policosanol , berberine , folic acid , coenzyme Q10 and asthaxantine can have beneficial effects on cardiovascular disease ( CVD ) biomarkers . The aim of this study was to assess whether the intake of AP , in combination with dietary recommendations , reduces serum low density lipoprotein cholesterol ( LDL-c ) concentrations and other CVD biomarkers in patients with hypercholesterolemia . Eligible patients were recruited from the outpatient clinics of six Spanish hospitals Hospital Virgen del Rocío ( Sevilla ) ; Hospital San Jorge ( Huesca ) ; Hospital San Pedro ( Logroño ) ; Hospital Gregorio Marañón ( Madrid ) , Hospital la Fe ( Valencia ) and Hospital Universitari Sant Joan ( Reus ) as recruiting and coordinating center . 102 participants ( mean age ± SD ; 50.91±11.61 ; 32 men ) with low CVD , with mild-to-moderately elevated LDL-c ( between 3.35 mmol/L and 4.88 mmol/L ) without hypolipemic therapy were r and omized in a double-blind , parallel , controlled , multicenter trial commencing January 2012 and ending December 2012 . Among the exclusion criteria were any concomitant chronic disease , triglycerides ( TG ) > 3.97 mmol/L , pregnant or lactating , and history of CVD . At 12 weeks , compared to placebo , AP reduced LDL-c by −6.9 % , apolipoprotein ( Apo ) B-100 by −6.6 % and total cholesterol/HDL-c ratio by −5.5 % , the ApoB/ApoA1 ratio by −8.6 % , while increasing ApoA1 by + 2.5 % ( p<0.05 ) . AP consumption was associated with modest mean weight loss of −0.93 kg ( 95%CI : -1.74 to -0.12 ; P = 0.02 ) compared with control group while dietary composition remained unchanged in the AP group . The AP product was well tolerated . In conclusion , AP , combined with dietary recommendations , reduced LDL-c levels as well as total cholesterol/HDL-c and ApoB/ApoA1 ratios , while increasing Apo A1 , all of which are improvements in CVD risk indicators . AP is a product which could benefit patients having moderate hyperlipidemia and excess body weight . Trial Registration Clinical Trials.gov Efficacy of a new patented proprietary combination of natural nutraceuticals ( PN ) containing natural hypolipidemic as red yeast , policosanol and berberine was tested in a large study on dyslipidemic patients in clinical practice . A parallel , controlled , r and omized , multicenter study was design ed . After 2 weeks on a stable dietary regimen , the patients were r and omized to PN 1 tablet/day associated with diet ( PN + D ) or diet alone ( D ) for 16 weeks . Entry criteria were : Tot-Chol > 200 mg/dL or LDL-Chol > 150 mg/dL without a clear indication for statins , or plasma triglycerides > 150 mg/dL.  Lipid pattern and CV parameters were evaluated at baseline and monthly . 1,751 patients were enrolled in 248 Italian units , 933 patients on PN + D and 818 on D. The baseline lipid values were : Tot-Chol 255.4 versus 243.1 mg/dL , LDL-Chol 170.1 versus 162.2 mg/dL , HDL-Chol 50.0 versus 48.8 mg/dL , and TG 190.5 versus 184.4 mg/dL. PN constantly and significantly improved lipid parameters versus D group : at 16 weeks −19.1 versus −9.4 % for Tot-Chol ( p < 0.001 ) , −23.5 versus −10.8 % for LDL-Chol ( p < 0.001 ) , + 11.6 versus + 4.0 % for HDL-Chol ( p < 0.001 ) , −17.9 versus −11.3 % for TG ( p < 0.001 ) . In conclusions , PN plus diet allows an effective improvement of blood lipids with a significant reduction of global CV risk , suggesting a role for PN in CHD prevention Introduction There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage . Methods This double-blind , placebo-controlled r and omized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice ( 10 mg ) , phytosterols ( 800 mg ) , and l-tyrosol ( 5 mg ) on lipid profile , blood pressure , endothelial function , and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet . Results After 8 weeks of treatment , when compared to the placebo group , the active treated patients experienced a more favorable percentage change in total cholesterol ( −16.3 % vs 9.9 % , P < 0.001 always ) , LDL-C ( −23.4 % vs −13.2 % , P < 0.001 always ) , and hepatic steatosis index ( −2.8 % , P < 0.01 vs −1.8 % , P < 0.05 ) . Moreover , ALT ( −27.7 % , P < 0.001 ) , AST ( −13.8 % , P = 0.004 ) , and serum uric acid ( −12.3 % , P = 0.005 ) were reduced by the tested nutraceutical compound both compared to r and omization and to placebo , which did not affect these parameters ( P < 0.01 for all ) . Regarding the hemodynamic parameters , there was a decrease of systolic blood pressure ( −5.6 % ) with the active treatment not observed with placebo ( P < 0.05 vs baseline and placebo ) and endothelial reactivity improved , too ( −13.2 % , P < 0.001 vs baseline ) . Consequently , the estimated 10-year cardiovascular risk score improved by 1.19 % ( SE 0.4 % ) ( P = 0.01 ) in the nutraceutical-treated patients . Conclusion The tested nutraceutical association is able to improve the positive effects of a Mediterranean diet on a large number of CV risk factors and consequently of the estimated CV risk . Trial registration Clinical Trials.gov identifier NCT02492464 . Funding IBSA Farmaceutici BACKGROUND AND AIMS Despite hypercholesterolemia has been recognized to increase cardiovascular risk in human immunodeficiency virus (HIV)-infected patients , cholesterol-lowering therapy is underused in this population , due to fear of drug-drug interactions with antiretroviral therapy ( ART ) . We investigated the effects of a nutraceutical combination ( NC ) on lipid profile , proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , sub clinical inflammation and arterial stiffness in ART-treated HIV-infected patients . METHODS This was a prospect i ve r and omized open-label trial with a cross-over design including 30 stable HIV-infected patients on ART with low-density lipoprotein cholesterol ( LDL-C ) > 115 mg/dL , not taking lipid-lowering treatment . After a 3-week lipid stabilization period , the effects associated with 3 months of an oral NC containing red yeast rice and berberine vs. no active treatment ( noNC ) were assessed for plasma total cholesterol ( TC ) , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , triglyceride ( TG ) , lipoprotein(a ) , PCSK9 , high-sensitivity C-reactive protein ( hs-CRP ) levels and aortic pulse wave velocity ( aPWV ) . RESULTS At baseline , significant correlations between PCSK9 levels , age ( rho = -0.51 , p=0.004 ) , waist circumference ( rho = 0.36 , p=0.005 ) and CD4 + cell count ( rho = -0.40 , p=0.027 ) were observed . NC treatment effects corrected for noNC were significant for TC ( -14 % , p<0.001 ) , LDL-C ( -19 % , p<0.001 ) , PCSK9 ( -12 % , p=0.02 ) , hs-CRP ( -14 % , p=0.03 ) and aPWV ( -6 % , p=0.005 ) . No significant effects were observed for HDL-C , TG and lipoprotein(a ) . NC treatment was safe and no significant alterations in muscle , liver and immunovirological parameters were observed . No carry over effect was recorded . CONCLUSIONS The tested NC significantly reduced plasma cholesterol and PCSK9 levels , attenuated sub clinical inflammation and improved arterial stiffness in stable HIV-infected patients on ART INTRODUCTION Dyslipidemia and high serum lipoprotein(a ) are among the risk factors for cardiovascular diseases in hemodialysis patients .  Statins as a first line of therapy in hyperlipidemia does not always reduce the serum lipoprotein(a ) level . Several studies have reported the lipid-lowering effects of carnitine and coenzyme Q10 in hemodialysis patients . This study was design ed to investigate the effects of carnitine and coenzyme Q10 on serum lipid profile and lipoprotein(a ) level in maintenance hemodialysis patients . MATERIAL S AND METHODS This was a r and omized placebo-controlled trial . We studied on hemodialysis patients who were on treatment with atorvastatin or lovastatin to assess the efficacy of supplement therapy . They were divided into 4 groups to receive carnitine , coenzyme Q10 , both carnitine and coenzyme Q10 , and placebo . After a 3-month experiment , blood sample s were collected to measure serum levels of lipoprotein(a ) , triglyceride , total cholesterol , high-density lipoprotein cholesterol and low-density lipoprotein cholesterol . RESULTS Fifty-two hemodialysis patients , 27 men and 25 women , completed the course of the study . Three months after supplement therapy , serum levels of lipoprotein(a ) reduced significantly in the carnitine , coenzyme Q10 , and combination groups compared to the baseline values and the 3-month value of lipoprotein(a ) in the placebo group ( P = .01 ) . Serum levels of triglyceride and other lipoproteins did not significantly alter . CONCLUSIONS Our study showed that supplementation with carnitine and coenzyme Q10 could reduce serum levels of lipoprotein(a ) in maintenance hemodialysis patients treated with statins Currently , no consensus has been reached regarding the management of hyperlipidemia in patients who develop statin-associated myalgia ( SAM ) . Many statin-intolerant patients use alternative lipid-lowering therapies , including red yeast rice . The present trial evaluated the tolerability of red yeast rice versus pravastatin in patients unable to tolerate other statins because of myalgia . The study was conducted in a community-based setting in Philadelphia , Pennsylvania . A total of 43 adults with dyslipidemia and a history of statin discontinuation because of myalgia were r and omly assigned to red yeast rice 2,400 mg twice daily or pravastatin 20 mg twice daily for 12 weeks . All subjects were concomitantly enrolled in a 12-week therapeutic lifestyle change program . The primary outcomes included the incidence of treatment discontinuation because of myalgia and a daily pain severity score . The secondary outcomes were muscle strength and plasma lipids . The incidence of withdrawal from medication owing to myalgia was 5 % ( 1 of 21 ) in the red yeast rice group and 9 % ( 2 of 22 ) in the pravastatin group ( p = 0.99 ) . The mean pain severity did not differ significantly between the 2 groups . No difference was found in muscle strength between the 2 groups at week 4 ( p = 0.61 ) , week 8 ( p = 0.81 ) , or week 12 ( p = 0.82 ) . The low-density lipoprotein cholesterol level decreased 30 % in the red yeast rice group and 27 % in the pravastatin group . In conclusion , red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction of low-density lipoprotein cholesterol in a population previously intolerant to statins CONTEXT Berberine , a natural plant alkaloid , is usually used as an antibiotic drug . The potential glucose-lowering effect of berberine was noted when it was used for diarrhea in diabetic patients . In vitro and in vivo studies have then showed its effects on hyperglycemia and dyslipidemia . OBJECTIVE The objective of the study was to evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia . DESIGN One hundred sixteen patients with type 2 diabetes and dyslipidemia were r and omly allocated to receive berberine ( 1.0 g daily ) and the placebo for 3 months . The primary outcomes were changes in plasma glucose and serum lipid concentrations . Glucose disposal rate ( GDR ) was measured using a hyperinsulinemic euglycemic clamp to assess insulin sensitivity . RESULTS In the berberine group , fasting and postload plasma glucose decreased from 7.0 + /- 0.8 to 5.6 + /- 0.9 and from 12.0 + /- 2.7 to 8.9 + /- 2.8 mm/liter , HbA1c from 7.5 + /- 1.0 % to 6.6 + /- 0.7 % , triglyceride from 2.51 + /- 2.04 to 1.61 + /- 1.10 mm/liter , total cholesterol from 5.31 + /- 0.98 to 4.35 + /- 0.96 mm/liter , and low-density lipoprotein-cholesterol from 3.23 + /- 0.81 to 2.55 + /- 0.77 mm/liter , with all parameters differing from placebo significantly ( P < 0.0001 , P < 0.0001 , P < 0.0001 , P = 0.001 , P < 0.0001 , and P < 0.0001 , respectively ) . The glucose disposal rate was increased after berberine treatment ( P = 0.037 ) , although no significant change was found between berberine and placebo groups ( P = 0.063 ) . Mild to moderate constipation was observed in five participants in the berberine group . CONCLUSIONS Berberine is effective and safe in the treatment of type 2 diabetes and dyslipidemia INTRODUCTION Dietary supplements provide a novel population based health approach for treating hyperlipidemias . Red yeast rice is known to have lipid lowering effects . Combination of red yeast rice with various oils is taken by different population around the world . AIM In this present work , we aim ed to compare the effects of red yeast rice with different oil ( coconut , rice bran and sunflower oil ) supplementations on lipid levels and oxidative stress in rats fed on hypercholesterolemic diet . MATERIAL S AND METHODS A R and omized controlled study was conducted on 28 male Sprague Dawley rats . It included 4 arms-Control arm ( hypercholesterolemic diet ) , Test arm A ( hypercholesterolemic diet + Red yeast rice + Rice bran oil ) , arm B ( hypercholesterolemic diet + Red yeast rice + Coconut oil ) and arm C ( hypercholesterolemic diet + Red yeast rice + Sunflower oil ) . At the end of one month , serum cholesterol , triglycerides , MDA and paraoxonase was measured . The mean values of analytes between the different groups were compared using student ' t- ' test . RESULTS The rats fed with red yeast rice and rice bran oil combination showed significantly lower levels of serum cholesterol , triglycerides and MDA when compared to the controls . The serum paraoxonase levels were significantly higher in this group when compared to the controls . The rats fed with red yeast rice and coconut oil combination showed significantly lower serum cholesterol and MDA levels when compared to the controls . The mean triglyceride and paraoxonase levels did not show any statistically significant difference from the controls . The rats on red yeast rice and sunflower oil combination did not show any statistically significant difference in the lipid levels and oxidative stress parameters . CONCLUSION The food combination which had best outcome in preventing the development of hyperlipidemia and oxidative stress in rats fed with hypercholesterolemic diet was red yeast rice and rice bran oil . Combining red yeast rice with coconut oil and sunflower oil gave suboptimal benefits OBJECTIVE Menopause is associated with broad , though generally not massive changes in a large number of metabolic parameters . The aim of our study was to evaluate the efficacy and tolerability of a combined nutraceutical approach on a large number of cardiometabolic risk markers and menopause symptoms in otherwise healthy , mildly dyslipidemic postmenopausal women . DESIGN / SETTING Forty women were enrolled in the context of a controlled , r and omized , prospect i ve study with parallel groups at the Lipid Clinic of the University of Bologna . INTERVENTION The women were r and omized to treatment with a nutraceuticals containing soy isoflavones ( 60 mg ) and berberine ( 500 mg ) or a placebo at a dosage of one tablet daily between meals for 12 weeks . RESULTS All patients completed the study without significant side effects . Anthropometric measures , blood pressure , HOMA index , and basal homocysteinemia significantly improved in isoflavones-berberine-treated group when compared to the baseline , but not when compared to the placebo-treated patients . Compared to placebo-treated patients , those treated with isoflavones-berberine experienced a significant improvement in plasma lipid and metalloproteinase serum levels , as well as the main menopausal symptoms . CONCLUSION The short-term consumption of a nutraceutical containing isoflavones and berberine was well-tolerated and improved menopausal symptoms , plasma lipid level , and serum levels of matrix metalloproteinases in a cohort of mildly dyslipidemic postmenopausal women when compared with a neutral control Ubiquinone is a lipid antioxidant , and a novel liquid ubiquinol ( a hydro-soluble , reduced form of coenzyme Q10 ) supplement was recently developed . The purpose of this study was to examine the levels of glucose , lipids and antioxidant capacity of type 2 diabetes patients after liquid ubiquinol supplementation .  This study was design ed as a r and omised , double-blind , placebo-controlled trial . In all , fifty participants were r and omly assigned to a placebo ( n 25 ) or liquid ubiquinol ( 100 mg/d , n 25 ) group , and the intervention lasted for 12 weeks . Plasma coenzyme Q10 , glucose homoeostasis parameters , lipid profiles , oxidative stress and antioxidative enzyme activities were measured during the study . After 12 weeks of supplementation , glyco Hb ( HbA1c ) value was significantly decreased in the liquid ubiquinol group ( P=0·03 ) , and subjects in the liquid ubiquinol group had significantly lower anti-glycaemic medication effect scores ( MES ) compared with those in the placebo group ( P=0·03 ) . The catalase ( P<0·01 ) and glutathione peroxidase ( P=0·03 ) activities were increased significantly after supplementation . Plasma coenzyme Q10 was correlated with the insulin level ( P=0·05 ) , homoeostatic model assessment -insulin resistance ( P=0·07 ) , quantitative insulin sensitivity check index ( P=0·03 ) and the anti-hyperglycaemic agents ' MES ( P=0·03 ) after supplementation . Lipid profiles did not change after supplementation ; however , the subjects in the placebo group had a significantly lower level of HDL-cholesterol after 12 weeks of intervention . In conclusion , oral intake of 100 mg/d liquid ubiquinol might benefit type 2 diabetes patients  by increasing antioxidant enzyme activity levels , reducing HbA1c levels and maintaining HDL-cholesterol levels Background : This study aim ed to investigate the possible relationships between adiponectin and leptin , blood lipids such as total cholesterol , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , and triglycerides ( TG ) as well as other clinical biomarkers in hyperlipidemia patients treated with red yeast rice .  Methods : 30 patients with primary hyperlipidemia were recruited , treated with red rice yeast capsules 600 mg twice a day for 8 weeks , and followed up for 4 weeks . The primary endpoint was the mean difference in LDL-C from baseline to week 8 , while the secondary endpoints were the mean percentage changes from baseline of total cholesterol , TG , HDL-C , adiponectin , and leptin . Results : At week 8 , the decrease in LDL-C and total cholesterol was -38.11 ± 30.90 mg/dl ( p < 0.0001 ) and -44.54 ± 27.46 mg/dl ( p < 0.0001 ) , respectively , and the increase in adiponectin was 35.83 ± 67.85 μg/ml ( p = 0.017 ) as compared to baseline . Adiponectin also correlated positively with HDL-C ( r2 = 0.39 ; p = 0.001 ) . Serum leptin correlated negatively with TG ( r2 = 0.19 ; p = 0.035 ) , and there was a trend of correlation between leptin and HDL-C , but this was not statistically significant ( r2 = 0.16 ; p = 0.052 ) . Conclusion : Red yeast rice can significantly increase adiponectin and can significantly lower LDL-C and total cholesterol levels . Adiponectin correlates positively with HDL-C while serum leptin correlates negatively with TG  . Red yeast rice has a potentially protective effect in obesity-related and cardiovascular diseases High blood glucose level , lipid profile disturbances and plasma homocysteine ( Hcy ) are important risk factors for cardiovascular diseases in patients with type 2 diabetes . This study was conducted to evaluate and compare effects of glimepiride/metformin combination versus gliclazide/metformin combination on cardiovascular risk factors in type-2 diabetes mellitus ( T2DM ) patients . One hundred and eighty T2DM patients were r and omly allocated for treatment with placebo ( control ) , metformin ( 500 mg twice daily ) , glimepiride ( 3 mg once daily ) , gliclazide ( 80 mg once daily ) , metformin plus glimepiride or metformin plus gliclazide for 3 months . We evaluated plasma levels of glucose ( PG ) , glycated hemoglobin ( HbA1C ) , Hcy , vitamin B12 , folic acid and lipid profile before treatment and 3 months post treatment . Compared to metformin treated patients , glimepiride plus metformin induced significant reductions in : fasting plasma glucose , postpr and ial PG level , HbA1C % and Hcy level . Conversely , plasma folic acid and vitamin B12 were significantly increased . The levels of total cholesterol and triglyceride were significantly decreased ; low-density lipoprotein was markedly decreased , whereas high-density lipoprotein was significantly increased and hence risk ratio was signiﬁcantly decreased . Similar results but with lower values were obtained using combination of metformin plus gliclazide on glycemic control only . Combination of glimepiride with metformin was superior to gliclazide plus metformin in alleviating the cardiovascular risk factors in type 2 diabetes mellitus patients Since the last publication of the recommendations for the management and treatment of dyslipidemia , new clinical trial data have emerged that support a more vigorous approach to lipid lowering in specific patient groups . The decision was made to up date the lipid guidelines in collaboration with the Canadian Cardiovascular Society . A systematic electronic search of medical literature for original research consisting of blinded , r and omized controlled trials was performed . Meta-analyses of studies of the efficacy and safety of lipid-lowering therapies , and of the predictive value of established and emerging risk factors were also review ed . All recommendations are evidence -based , and have been review ed in detail by primary and secondary review panels . Major changes include a lower low-density lipoprotein cholesterol ( LDL-C ) treatment target ( lower than 2.0 mmol/L ) for high-risk patients , a slightly higher intervention point for the initiation of drug therapy in most low-risk individuals ( LDL-C of 5.0 mmol/L or a total cholesterol to high-density lipoprotein cholesterol ratio of 6.0 ) and recommendations regarding additional investigations of potential use in the further evaluation of coronary artery disease risk in subjects in the moderate-risk category Background In recent years , red yeast rice ( RYR ) supplements have been marketed aggressively as a natural way to lower cholesterol ; however , the large majority of commercially available products have not been studied according to current research st and ards . Methods In a double blind placebo controlled r and omized trial , 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were r and omly allocated to receive a RYR extract or placebo for 8 weeks . As a primary outcome measure , we compared the before-after difference in lipid levels between both groups . As secondary outcome measures we looked at side-effects , CK elevation and a change in cardiovascular risk . Results LDL ( low density lipoprotein ) cholesterol was lowered with 36 mg/dL ( 22 % ) and total cholesterol with 37 mg/dL ( 15 % ) in the intervention group . This result was statistically significant as compared to the control group , in which no reduction in total cholesterol and LDL was observed ( p < 0.001 ) . There was no marked difference in CK ( creatine kinase)-elevation or reported side-effects between study groups . In 5/31 participants in the intervention group , the lipid lowering effect result ed in lower cardiovascular risk as measured with SCORE ( Systematic COronary Risk Evaluation ) . Conclusions The RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population . RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering . However , consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations , which raises effectiveness and safety issues . Trial registration Clinical trials.gov , nr : Adhesion molecules , particularly intracellular adhesion molecule (ICAM)-1 , vascular cell adhesion molecule (VCAM)-1 , and E-selectin , have been associated with cardiovascular disease . Elevated levels of these molecules have been reported in diabetic patients . Postpr and ial hypertriglyceridemia and hyperglycemia are considered risk factors for cardiovascular disease , and evidence suggests that postpr and ial hypertriglyceridemia and hyperglycemia may induce an increase in circulating adhesion molecules . However , the distinct role of these two factors is a matter of debate . Thirty type 2 diabetic patients and 20 normal subjects ate three different meals : a high-fat meal , 75 g of glucose alone , and a high-fat meal plus glucose .  Glycemia , triglyceridemia , plasma nitrotyrosine , ICAM-1 , VCAM-1 , and E-selectin were assayed during the tests . Subsequently , diabetic subjects took simvastatin 40 mg/day or placebo for 12 weeks . The three tests were performed again at baseline , between 3 and 6 days after starting the study , and at the end of each study . High-fat load and glucose alone produced an increase of nitrotyrosine , ICAM-1 , VCAM-1 , and E-selectin plasma levels in normal and diabetic subjects . These effects were more pronounced when high fat and glucose were combined . Short-term simvastatin treatment had no effect on lipid parameters , but reduced the effect on adhesion molecules and nitrotyrosine , which was observed during every different test . Long-term simvastatin treatment was accompanied by a lower increase in postpr and ial triglycerides , which was followed by smaller variations in ICAM-1 , VCAM-1 , E-selectin , and nitrotyrosine during the tests . This study shows an independent and cumulative effect of postpr and ial hypertriglyceridemia and hyperglycemia on ICAM-1 , VCAM-1 , and E-selectin plasma levels , suggesting oxidative stress as a common mediator of such effects . Simvastatin shows a beneficial effect on oxidative stress and the plasma levels of adhesion molecules , which may be ascribed to a direct effect in addition to the lipid-lowering action of the drug Increased blood homocysteine is a potentially modifiable risk factor for cardiovascular disease . In a recent meta analysis of individual participant data from prospect i ve epidemiologic studies , a 25 % lower homocysteine concentration was associated with an 11 % lower risk for ischemic heart disease and a 19 % lower risk for stroke ( 1 ) . Blood homocysteine is easily lowered by folic acid supplementation , and several large-scale r and omized trials are currently underway to assess the effects of homocysteine-lowering vitamin supplements on the risk of vascular disease . If such trials demonstrate benefit , there will be increasing interest in homocysteine determinations to assess vascular disease risk . In addition , further large-scale epidemiologic studies may be required to investigate the association between homocysteine and cardiovascular disease in a wider range of population s. These would be facilitated by simple and cost-effective methods for blood collection and analysis . One of the chief constraints in homocysteine measurements is the continuing production and release of homocysteine by red blood cells after venipuncture , which causes an artificial increase in plasma concentration of ∼10 % per hour (2)(3 ) . It has been recommended , therefore , that blood sample s for homocysteine measurements be drawn into tubes containing EDTA , chilled , or placed on ice immediately after collection and that the plasma be separated from the red cells within 1 h. Such procedures can be difficult to implement in large-scale epidemiologic studies or other situations in which sample s have to be collected remotely ( e.g. , in multiple clinics or in people ’s homes ) and transported to a central laboratory . Use of NaF or acidic citrate has been advocated for stabilization of homocysteine in whole blood at ambient temperature To test the effects of combined coenzyme Q10 ( Q10 ) and d-alpha-tocopheryl acetate supplementation on exercise-induced oxidative stress and muscular damage we conducted a double-blind study in 37 moderately trained male marathon runners . These were r and omly allocated to receive either an antioxidant cocktail : 90 mg of Q10 and 13.5 mg of d-alpha-tocopheryl acetate daily ( 18 men ) or placebo ( 19 men ) for three weeks before a marathon ( 42 km ) run . Just before the run , plasma Q10 was 282 % ( p < 0.0001 ) and plasma  vitamin E 16 % ( p < 0.007 ) higher in the supplemented group , than in the placebo group . Also the proportion of plasma ubiquinol of total Q10 , an indication of plasma redox status in vivo , was significantly higher in the supplemented group . Furthermore , the susceptibility of the VLDL + LDL fraction , to copper-induced oxidation , was significantly reduced in the supplemented group , compared to the placebo group . The exercise increased lipid peroxidation significantly in both study groups , as assessed by the elevated proportion LDL of LDL and the increased susceptibility of lipoproteins to copper induced oxidation . However , the supplementation had no effect on lipid peroxidation or on the muscular damage ( increase in serum creatine kinase activity or in plasma lactate levels ) induced by exhaustive exercise . Plasma ascorbate , Q10 , whole blood glutathione and serum uric acid concentrations increased during the exercise , elevating significantly the TRAP value of plasma by 10.3 % and the proportion of plasma ubiquinol of total Q10 by 4.9 % . These results suggest that even though exercise increases plasma lipid peroxidation , it also elevates the antioxidative capacity of plasma , as assessed by the increased plasma TRAP and the proportion of Q10H2 of total Q10 . However , prior supplementation with small doses of Q10 and d-alpha-tocopheryl acetate neither attenuates the oxidation of lipoproteins nor muscular damage induced by exhaustive exercise such as encountered in a marathon run The aim of this study was to evaluate the serum coenzyme Q10 concentrations of healthy elderly women before and after supplementation with coenzyme Q10 combined with multivitamins , selenium , and magnesium . In a r and omized double-blind design , 220 free-living women aged 60 years and older were included . Median serum coenzyme Q10 concentration at baseline was 0.99 mumol/L ( 5 - 95 percentiles : 0.54 - 1.68 ) and cholesterol adjusted concentration was 0.16 ( 5 - 95 percentiles : 0.09 - 0.26 ) mmol/mol cholesterol . No significant correlations were found between Q10 levels and body mass index ( BMI ) or age . Q10 concentrations were not significantly different between smoking and nonsmoking women , nor between women with statin therapy and without . Furthermore no differences were seen between hyperlipidemic and normolipidemic subjects . Cholesterol-adjusted Q10 levels were positively correlated to lipid-adjusted serum tocopherol levels and negatively associated to serum beta-carotene . No significant correlation existed between adjusted Q10 levels and plasma selenium . Results of the food diaries showed a significant but weak correlation to meat and meat products and to alcohol intake . At baseline , Q10 levels did not differ between supplemented and control group . After six months , adjusted serum concentrations of the supplemented and the control group were significantly increased by 106 % and 31 % , respectively . In the supplemented group the change was inversely associated with the baseline concentration . A six-month supplementation with coenzyme Q10 , vitamins , and selenium raises the blood concentration of coenzyme Q10 even in relatively well-nourished elderly women
NComb-induced amelioration of lipid profile was not affected by duration of supplementation nor by baseline lipid levels ; conversely , a greater glucose-lowering effect of NComb was found with higher baseline glucose levels and longer duration s of supplementation .
In conclusion , the present results suggest that NComb supplementation is associated with improvement of lipid and glucose profile .
Short-term beneficial effects of NComb supplementation appear to be maintained in the long term
Dyslipidemia and hyperglycemia are associated with an increased risk of  ischemic cardiovascular disease .
Positive effects of a nutraceutical combination comprising red yeast rice , berberine , policosanol , astaxanthin , coenzyme Q10 and folic acid ( NComb ) on plasma lipid and glucose levels have been reported in some but not all clinical trials .
To address this inconsistency , we tried to estimate the size of lipid- and glucose-lowering effects of NComb through a systematic review and meta- analysis of r and omized controlled trials .