Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. 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. Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet 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 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 Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease. Effects of Concomitant Administration of a Dipeptidyl Peptidase-4 Inhibitor in Japanese Patients with Type 2 Diabetes Showing Relatively Good Glycemic Control Under Treatment with a Sodium Glucose Co-Transporter 2 Inhibitor. Relationship between Adiponectin and Leptin, and Blood Lipids in Hyperlipidemia Patients Treated with Red Yeast Rice 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 Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis Docosahexaenoic acid restores endothelial function in children with hyperlipidemia: results from the EARLY study. A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients: impact on cardiovascular risk reduction. Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. Effect of sesame seed on lipid profile and redox status in hyperlipidemic patients Comparison of the effects of simultaneous administration of vitamin C and omega-3 fatty acids on lipoproteins, apo A-I, apo B, and malondialdehyde in hyperlipidemic patients. Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the assessment of diabetes control and evaluation of the efficacy of niaspan trial.
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 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 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 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 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 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 We conducted this study to determine whether additional administration of a dipeptidyl peptidase-4 ( DPP-4 ) inhibitor might provide further improvement of the glycemic control in Japanese type 2 diabetes patients showing relatively good glycemic control under treatment with a sodium glucose co-transporter 2 ( SGLT2 ) inhibitor . Five SGLT2 inhibitor ( luseogliflozin , dapagliflozin , tofogliflozin , empagliflozin and canagliflozin ) preparations and five DPP-4 inhibitor ( sitagliptin , vildagliptin , alogliptin , anagliptin and linagliptin ) preparations were used . The results showed that monotherapy with SGLT2 inhibitor produced significant decreases of the body weight and BMI , hemoglobin A1c ( HbA1c ) also decreased , but not to a significant extent . However , decreases of the serum aspartate aminotransferase ( AST ) , alanine aminotransferase ( ALT ) , γ-glutamyltransferase ( γ-GTP ) and uric acid were observed in this group . On the other h and , in type 2 diabetes patients treated concomitantly with a DPP-4 inhibitor and SGLT2 inhibitor , significant decrease of the HbA1c was observed , indicating the favorable effect of the concomitant therapy . The body weight and BMI decreased . As for the serum lipid profile , elevation of the serum HDL-cholesterol ( HDL-C ) was observed . Furthermore , AST , ALT , γ-GTP and uric acid decreased in the combined treatment group . Then , the therapeutic responses to concurrent administration with SGLT2 inhibitor of each of the 5 individual DPP-4 inhibitors used in this study were analyzed . The results showed that concomitant administration of sitagliptin , a DPP-4 inhibitor , with the SGLT2 inhibitor yielded the best results in terms of the lowering of the HbA1c and improvement of the serum lipid profile 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 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 Purpose Metabolic disturbances are quite common in critically ill patients . Glycemic control appears to be an important adjuvant therapy in such patients . In addition , disorders of lipid metabolism are associated with worse prognoses . The purpose of this study was to investigate the effects that two different glycemic control protocol s have on lipid profile and metabolism . Methods We evaluated 63 patients hospitalized for severe sepsis or septic shock , over the first 72 h of intensive care . Patients were r and omly allocated to receive conservative glycemic control ( target range 140–180 mg/dl ) or intensive glycemic control ( target range 80–110 mg/dl ) . Serum levels of low-density lipoprotein , high-density lipoprotein , triglycerides , total cholesterol , free fatty acids , and oxidized low-density lipoprotein were determined . Results In both groups , serum levels of low-density lipoprotein , high-density lipoprotein , and total cholesterol were below normal , whereas those of free fatty acids , triglycerides , and oxidized low-density lipoprotein were above normal . At 4 h after admission , free fatty acid levels were higher in the conservative group than in the intensive group , progressively decreasing in both groups until hour 48 and continuing to decrease until hour 72 only in the intensive group . Oxidized low-density lipoprotein levels were elevated in both groups throughout the study period . Conclusions Free fatty acids respond to intensive glycemic control and , because of their high toxicity , can be a therapeutic target in patients with sepsis OBJECTIVE The primary objective of this study was to determine whether the National Cholesterol Education Program Step II ( NCEP-II ) diet or supplementation with docosahexaenoic acid ( DHA ) with the diet , affects endothelial function in children with familial hypercholesterolemia ( FH ) or the phenotype of familial combined hyperlipidemia ( FCH ) . As secondary endpoints , the influence of diet and DHA supplementation on lipid profiles as well as biomarkers for oxidative stress and inflammation , and asymmetric dimethylarginine ( ADMA ) , an endogenous inhibitor of nitric oxide synthase , were all evaluated . METHODS In a double-blind , placebo-controlled , r and omized , crossover study design , 20 children ( ages 9 - 19 years ) with FH ( n = 12 ) and FCH ( n = 8) received nutritional counseling based on the National Cholesterol Education Program Step II ( NCEP-II ) and food guide pyramid dietary guidelines for 6 weeks . They were then r and omly assigned to supplementation with docosahexaenoic acid ( DHA 1.2 g/d ) or placebo for 6 weeks , followed by a washout phase of 6 weeks and crossover phase of 6 weeks while continuing the NCEP-II diet . Endothelium-dependent flow-mediated dilation ( FMD ) of the brachial artery was determined by high-resolution ultrasound . Plasma levels of total cholesterol , triglycerides and lipoprotein classes ( LDL , HDL , VLDL ) were measured by ultracentrifugation and enzymatic methods , plasma F2 isoprostanes by gas chromatography/mass spectrometry , urinary 8-OH-2 ' deoxyguanosine by liquid chromatography , high sensitivity C-reactive protein by immunonephelometry and ADMA by liquid chromatography . RESULTS FMD increased significantly after DHA supplementation compared to baseline ( p < 0.001 ) , diet alone ( p < 0.002 ) , placebo ( p < 0.012 ) and washout ( p < 0.001 ) phases of the study without affecting biomarkers for oxidative stress , inflammation or ADMA . DHA supplementation was associated with increased levels of total cholesterol ( p < 0.01 ) , LDL- and HDL cholesterol concentrations ( p < 0.001 ) compared to the NCEP-II diet . CONCLUSION This study demonstrates that DHA supplementation restores endothelial-dependent FMD in hyperlipidemic children . The endothelium may thus be a therapeutic target for DHA . This is consistent with a hypothesis of increasing NO bioavailability , with the potential for preventing the progression of early coronary heart disease in high-risk children OBJECTIVE To assess the long-term effects of a prepackaged , nutritionally complete , prepared meal plan compared with a usual-care diet ( UCD ) on weight loss and cardiovascular risk factors  in overweight and obese persons . DESIGN In this r and omized multicenter study , 302 persons with hypertension and dyslipidemia ( n = 183 ) or with type 2 diabetes mellitus ( n = 119 ) were r and omized to the nutrient-fortified prepared meal plan ( approximately 22 % energy from fat , 58 % from carbohydrate , and 20 % from protein ) or to a macronutrient-equivalent UCD . MAIN OUTCOME MEASURES The primary outcome measure was weight change . Secondary measures were changes in blood pressure or plasma lipid , lipoprotein , glucose , or glycosylated hemoglobin levels ; quality of life ; nutrient intake ; and dietary compliance . RESULTS After 1 year , weight change in the hypertension/dyslipidemia group was -5.8+/-6.8 kg with the prepared meal plan vs -1.7+/-6.5 kg with the UCD plan ( P<.001 ) ; for the type 2 diabetes mellitus group , the change was -3.0+/-5.4 kg with the prepared meal plan vs -1.0+/-3.8 kg with the UCD plan ( P<.001 ) ( data given as mean + /- SD ) . In both groups , both interventions improved blood pressure , total and low-density lipoprotein cholesterol levels , glycosylated hemoglobin level , and quality of life ( P<.02 ) ; in the diabetic group , the glucose level was reduced ( P<.001 ) . Compared with those in the UCD group , participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total ( P<.01 ) and high-density lipoprotein ( P<.03 ) cholesterol levels , systolic blood pressure ( P<.03 ) , and glucose level ( P<.03 ) ; in participants with type 2 diabetes mellitus , there were greater improvements in glucose ( P = .046 ) and glycosylated hemoglobin ( P<.02 ) levels . The prepared meal plan group also showed greater improvements in quality of life ( P<.05 ) and compliance ( P<.001 ) than the UCD group . CONCLUSIONS Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients . The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular  risk Results of well-controlled prospect i ve clinical trials showed the efficacy of lipid-lowering therapies in the reduction of cardiovascular ( CV ) events in western population s , but they were not reported with a Chinese population . This multicenter study was conducted to determine the effects of Xuezhikang ( XZK ) , a partially purified extract of red yeast rice , on lipoprotein and CV end points in Chinese patients who experienced a previous myocardial infa rct ion . Nearly 5,000 of these patients with average low-density lipoprotein cholesterol levels at baseline were r and omly assigned either to placebo or to XZK daily for an average of 4.5 years . The primary end point was a major coronary event that included nonfatal myocardial infa rct ion and death from coronary heart disease . Frequencies of the primary end point were 10.4 % in the placebo group and 5.7 % in the XZK-treated group , with absolute and relative decreases of 4.7 % and 45 % , respectively . Treatment with XZK also significantly decreased CV and total mortality by 30 % and 33 % , the need for coronary revascularization by 1/3 , and lowered total and low-density lipoprotein cholesterol and triglycerides , but raised high-density lipoprotein cholesterol levels . In conclusion , long-term therapy with XZK significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths , improved lipoprotein regulation , and was safe and well tolerated Pre- clinical studies suggest that sesame and its lignans induce beneficial changes in risk factors related to cardiovascular disease . This study was design ed to investigate the effects of sesame on reducing serum lipids and enhancing antioxidant capacity in 38 hyperlipidemic patients who were divided into two groups r and omly . For all individuals along the 60 days of study period , the same drug treatments were considered . Intervention group patients were supposed to eat 40 g white sesame seeds daily , and instead of these calories , 240 kcal was removed from their diet . Anthropometric measurements including height , weight and body mass index ( BMI ) were measured . We assessed lipid profile and oxidative stress indicators such as glutathione peroxidase ( GPX ) , superoxide dismutase ( SOD ) and thiobarbituric acid reactive substances ( TBARS ) before and after the intervention . Significant differences among and between the groups were determined by independent t-test and paired sample t-test using 13th version of statistical package for the social sciences . The results showed that the diet with sesame significantly decreased the levels of serum total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) and TC/HDL-C ratio . Lipid peroxidation ( TBARS ) decreased while the activities of GPX and SOD were increased . There were no significant changes in anthropometric indexes such as weight and BMI after consumption of sesame . The results suggested that sesame seed supplementation decreased serum TC , LDL-C and lipid peroxidation , and increased antioxidant status in hyperlipidemic patients BACKGROUND Control of hyperlipidemia is vital in patients with cardiovascular disease ( CVD ) .  Omega-3 fatty acids ( n-3FAs ) have desirable effects on serum triglyceride ( TG ) levels , thrombosis , and arrhythmia , but lead to increases in serum low-density lipoprotein ( LDL ) and apo-B as well . OBJECTIVE To determine and compare the effects of administration of n-3FAs , vitamin C ( VitC ) and n-3FAs + VitC on the serum levels of LDL , apoB , other serum lipids , and malondialdehyde ( MDA ) . The present study was performed in Tehran University of Medical Sciences from 2000 to 2001 . DESIGN In a double-blind , placebo trial of parallel design , 68 hyperlipidemic patients [ total cholesterol ( TC ) and TG greater than 200 mg/dL ] were r and omly assigned to receive daily 500 mg VitC , 1 g n-3FAs , 500 mg VitC + 1 g n-3FAs , or placebo ( control ) for 10 weeks . Fasting blood sample s were collected at the beginning and at the end of the period . TG , TC , LDL-cholesterol-C ( LDL-C ) , and high-density lipoprotein-cholesterol ( HDL-C ) were measured enzymatically , VitC and MDA colorimetrically , and apo-B and apo-A-I immunoturbidometrically . The pattern of food consumption , socio-economic , and anthropometric indices were determined ; there was no significant change in these indices during the study . RESULTS There was a significant difference in the blood VitC level at the end of the study in comparison to the initial value in the VitC ( p = 0.001 ) and VitC + n-3FAs ( p = 0.027 ) groups . Similarly , the serum TG level at the end of study was significantly different from the initial value in the n-3FAs group ( p = 0.002 ) and also from the final value in the control group ( p = 0.013 ) . In the VitC group , there was a significant decrease in TC ( p = 0.004 ) , apo-B ( p = 0.005 ) , and MDA ( p = 0.015 ) at the end of study as compared to the respective initial values . There was also a significant increase in blood VitC compared to the control value ( p = 0.018 ) and a significant decrease in MDA compared to the n-3FAs group ( p = 0.034 ) . At the end of study , in the n-3FAs group , there was a significant ( p = 0.04 ) and a marginally significant decrease ( p = 0.05 ) , respectively , in TG/HDL and apo-B levels as compared to the initial values , and the TG/HDL ratio showed a significant decrease as compared to the control group ( p = 0.047 ) . CONCLUSION Simultaneous administration of n-3FAs and VitC had no beneficial effects on the lipid profile of hyperlipidemic patients , but 1 g purified n-3FAs daily for 10 weeks is a beneficial supplement for decreasing TG without any increase in LDL-C , apo-B or MDA . Administration of 500 mg VitC for more than 10 weeks might decrease significantly TC and apo-B in hyperlipidemic patients BACKGROUND Diabetic dyslipidemia is characterized by high triglyceride levels ; low high-density lipoprotein cholesterol levels ; small , dense low-density lipoprotein particles ; and high free fatty acid levels . Niacin reduces concentrations of triglyceride-rich and small low-density lipoprotein particles while increasing high-density lipoprotein cholesterol levels . It also lowers levels of free fatty acids and lipoprotein(a ) . However , the use of niacin in patients with diabetes has been discouraged because high doses can worsen glycemic control . We evaluated the efficacy and safety of once-daily extended-release ( ER ) niacin in patients with diabetic dyslipidemia . METHODS During a 16-week , double-blind , placebo-controlled trial , 148 patients were r and omized to placebo  ( n = 49 ) or 1000 ( n = 45 ) or 1500 mg/d ( n = 52 ) of ER niacin .  Sixty-nine patients ( 47 % ) were also receiving concomitant therapy with statins .  RESULTS Dose-dependent increases in high-density lipoprotein cholesterol levels ( + 19 % to + 24 % [ P<.05 ] vs placebo for both niacin dosages ) and reductions in triglyceride levels ( -13 % to -28 % [ P<.05 ] vs placebo for the 1500-mg ER niacin ) were observed . Baseline and week 16 values for glycosylated hemoglobin levels were 7.13 % and 7.11 % , respectively , in the placebo group ; 7.28 % and 7.35 % , respectively , in the 1000-mg ER niacin group ( P=.16 vs placebo ) ; and 7.2 % and 7.5 % , respectively , in the 1500-mg ER niacin group ( P=.048 vs placebo ) . Four patients discontinued participation because of inadequate glucose control . Rates of adverse event rates other than flushing were similar for the niacin and placebo groups . Four patients discontinued participation owing to flushing ( including 1 receiving placebo ) . No hepatotoxic effects or myopathy were observed . CONCLUSION Low doses of ER niacin ( 1000 or 1500 mg/d ) are a treatment option for dyslipidemia in patients with type 2 diabetes
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 .