human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective : To assess the effects of soybean-derived pinitol on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus . Design : R and omized , double-blind , placebo-controlled , parallel-group trial . Setting : Pusan Paik Hospital , Pusan , Republic of Korea . Interventions : A total of 30 patients with type II diabetes received an oral dose of 600 mg soybean-derived pinitol or placebo twice daily for 13 weeks . Results : Pinitol significantly decreased mean fasting plasma glucose , insulin , fructosamine , HbA1c , and the homeostatic model assessment insulin resistance index ( HOMA-IR , P<0.001 ) . Pinitol significantly decreased total cholesterol , LDL-cholesterol , the LDL/HDL-cholesterol ratio , and systolic and diastolic blood pressure and increased HDL-cholesterol ( P<0.05 ) . Conclusions : These data suggest that soybean-derived pinitol may be beneficial in reducing cardiovascular risk in Korean type II diabetes . Sponsorship : This study was supported by a grant of the Korea Health 21 R&D Project , Ministry of Health & Welfare , Republic of Korea ( HMP 02-PJ1-PG3 - 22005 - 0011 ) OBJECTIVE To determine whether the administration of D-chiro-inositol , a putative insulin-sensitizing drug , would affect the concentration of circulating insulin , the levels of serum and rogens , and the frequency of ovulation in lean women with the polycystic ovary syndrome . METHODS In 20 lean women ( body mass index , 20.0 to 24.4 kg/m 2 ) who had the polycystic ovary syndrome , treatment was initiated with either 600 mg of D-chiro-inositol or placebo orally once daily for 6 to 8 weeks . We performed oral glucose tolerance tests and measured serum sex steroids before and after therapy . To monitor for ovulation , we determined serum progesterone concentrations weekly . RESULTS In the 10 women given D-chiro-inositol , the mean ( + /- st and ard error ) area under the plasma insulin curve after oral administration of glucose decreased significantly from 8,343 + /- 1,149 mU/mL per min to 5,335 + /- 1,792 mU/mL per min in comparison with no significant change in the placebo group ( P = 0.03 for difference between groups ) . Concomitantly , the serum free testosterone concentration decreased by 73 % from 0.83 + /- 0.11 ng/dL to 0.22 + /- 0.03 ng/dL , a significant change in comparison with essentially no change in the placebo group ( P = 0.01 ) . Six of the 10 women ( 60 % ) in the D-chiro-inositol group ovulated in comparison with 2 of the 10 women ( 20 % ) in the placebo group ( P = 0.17 ) . Systolic ( P = 0.002 ) and diastolic ( P = 0.001 ) blood pressures , as well as plasma triglyceride concentrations ( P = 0.001 ) , decreased significantly in the D-chiro-inositol group in comparison with the placebo group , in which these variables either increased ( blood pressure ) or decreased minimally ( triglycerides ) . CONCLUSION We conclude that , in lean women with the polycystic ovary syndrome , D-chiro-inositol reduces circulating insulin , decreases serum and rogens , and ameliorates some of the metabolic abnormalities ( increased blood pressure and hypertriglyceridemia ) of syndrome 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 Background and Aim . Cardiovascular risk is increased in women with menopause and metabolic syndrome . Aim of this study was to test the effect of a new supplement formula , combining cocoa polyphenols , myo-inositol , and soy isoflavones , on some biomarkers of cardiovascular risk in postmenopausal women with metabolic syndrome . Methods and Results . A total of 60 women were enrolled and r and omly assigned ( n = 30 per group ) to receive the supplement ( NRT : 30 mg of cocoa polyphenols , 80 mg of soy isoflavones , and 2 gr of myo-inositol ) , or placebo for 6 months . The study protocol included three visits ( baseline , 6 , and 12 months ) for the evaluation of glucose , triglycerides , and HDL-cholesterol ( HDL-C ) , adiponectin , visfatin , resistin , and bone-specific alkaline phosphatase ( bone-ALP ) . At 6 months , a significant difference between NRT and placebo was found for glucose ( 96 ± 7 versus 108 ± 10 mg/dL ) , triglycerides ( 145 ± 14 versus 165 ± 18 mg/dL ) , visfatin ( 2.8 ± 0.8 versus 3.7 ± 1.1 ng/mL ) , resistin ( 27 ± 7 versus 32 ± 8 µg/L ) , and b-ALP ( 19 ± 7 versus 15 ± 5 µg/mL ) . No difference in HDL-C concentrations nor in adiponectin levels between groups was reported at 6 months . Conclusions . The supplement used in this study improves most of the biomarkers linked to metabolic syndrome . This Trial is registered with NCT01400724 BACKGROUND AND AIMS Prospect i ve studies have demonstrated that the risk of death due to ischaemic heart disease is strongly correlated with blood cholesterol ( TC ) levels . Diet is the basic treatment for all dyslipidaemia . If diet alone proves inadequate , supplements can be used to try to reduce cholesterol levels . These substances are indicated in moderate dyslipidaemia , as they are able to induce a moderate reduction in blood cholesterol . The objective of our study was to investigate the effects of a dietary supplement containing Omega-3 , Policosanol , Resveratrol , L-carnitine , Monascus purpureus , Coenzyme Q10 , Vitamin B6 and Vitamin B12 on TC ( primary end point ) and LDL , triglycerides and HDL ( secondary endpoints ) . PATIENTS AND METHODS The study involved 40 men and 40 women recruited from the outpatient section of our Department r and omly assigned to the treatment group ( A ) or the control group ( B ) . RESULTS There was a statistically significant reduction in TC 6 months after the end of treatment in both groups . In Group A , there was also a statistically significant change in HDL , LDL and TG , while in group B , there was no statistically significant change in HDL , LDL or TG . CONCLUSIONS The dietary supplement used in our study , in combination with a balanced diet and physical exercise , was found to induce a significant reduction in TC and LDL-C and an improvement in HDL-C. In contrast , while a balanced diet together with physical exercise but without the dietary supplement produced a significant reduction in TC , it had no significant effect on the other lipid parameters tested BACKGROUND Obese women with polycystic ovary syndrome ( PCOS ) manifest impaired insulin-stimulated release of a d-chiro-inositol-containing inositolphosphoglycan ( DCI-IPG ) insulin mediator during oral glucose tolerance testing ( OGTT ) , which appears to be restored by the administration of metformin . This suggests that either obesity or PCOS is associated with a defect in the coupling of the stimulation of the insulin receptor by insulin to the release of the DCI-IPG mediator . The objective of this study was to compare the release of bioactive DCI-IPG between normal nonobese women and obese PCOS women during stimulation with two different concentrations of insulin when glucose levels are clamped . METHODS We performed a cross-sectional case-control study at the clinical research center of an academic medical center . A two-step euglycemic-hyperinsulinemic clamp was carried out in 8 nonobese normal and 8 obese PCOS women , during which DCI-IPG bioactivity was monitored . RESULTS At baseline , PCOS women were significantly more obese , hyperinsulinemic , and insulin resistant than the controls . During the clamp studies , DCI-IPG bioactivity increased significantly over the first 45 min of the low-insulin step of the clamp in normal nonobese women ( P = 0.046 ) and then decreased to baseline levels ; DCI-IPG increased again after initiation of the high-insulin step ( P = 0.029 ) . Despite higher insulin levels during the clamp in PCOS women , DCI-IPG bioactivity remained flat throughout both insulin steps and was thus significantly lower than in controls during the initial periods of both steps . CONCLUSIONS The coupling between insulin action and the release of the DCI-IPG mediator is selectively impaired in obese PCOS women , which may contribute to the insulin resistance in these women DESIGN AND PURPOSE The supplemental administration of myo-inositol , D-chiro-inositol , folic acid and manganese ( MDFM ) was tested in a prospect i ve , r and omized , double-blind , placebo controlled clinical trial , pilot study , to test the hypothesis that its supplemental administration in the second trimester of pregnancy would improve glucose and glycemic parameters and blood pressure . SUBJECTS AND METHODS Non-obese uniparous healthy pregnant women between 13th and 24th week of pregnancy were divided into two groups : group I , control group with placebo , and the group II , women in treatment with myo-inositol , D-chiro-inositol , folic acid and manganese . The main outcome measures were the comparative analysis of the parameters analyzed at time 0 , after 30 days and 60 days ; secondary outcome measure was the overall analysis of investigated parameters . RESULTS 24 women were allocated to receive MDFM and 24 the placebo . The two groups did not significantly differ for demographic , lipidic and glycemic parameter and blood pressure . After 30 days , significantly lower cholesterol ( p = 0.0001 ) , significantly lower LDL ( p = 0.0013 ) , lower TG ( p < 0.0001 ) and lower glycemia ( p = 0.0021 ) were observed all favoring group II . No significant difference was observed for HDL , diastolic and systolic blood pressure . After 60 days , significant difference was observed for cholesterol ( p = 0.0001 ) , LDL ( p = 0.0001 ) , HDL ( p = 0.0001 ) , TG ( p = 0.0001 ) , glycemia ( p = 0.0064 ) , all favoring the group treated with M 
    Output:
    
agent
Conclusions Inositol supplementation may result in reduction in triglycerides , total- and LDL-cholesterol levels , but did not affect HDL-cholesterol levels  among patients with metabolic diseases .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective : To assess the effects of soybean-derived pinitol on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus . Design : R and omized , double-blind , placebo-controlled , parallel-group trial . Setting : Pusan Paik Hospital , Pusan , Republic of Korea . Interventions : A total of 30 patients with type II diabetes received an oral dose of 600 mg soybean-derived pinitol or placebo twice daily for 13 weeks . Results : Pinitol significantly decreased mean fasting plasma glucose , insulin , fructosamine , HbA1c , and the homeostatic model assessment insulin resistance index ( HOMA-IR , P<0.001 ) . Pinitol significantly decreased total cholesterol , LDL-cholesterol , the LDL/HDL-cholesterol ratio , and systolic and diastolic blood pressure and increased HDL-cholesterol ( P<0.05 ) . Conclusions : These data suggest that soybean-derived pinitol may be beneficial in reducing cardiovascular risk in Korean type II diabetes . Sponsorship : This study was supported by a grant of the Korea Health 21 R&D Project , Ministry of Health & Welfare , Republic of Korea ( HMP 02-PJ1-PG3 - 22005 - 0011 ) OBJECTIVE To determine whether the administration of D-chiro-inositol , a putative insulin-sensitizing drug , would affect the concentration of circulating insulin , the levels of serum and rogens , and the frequency of ovulation in lean women with the polycystic ovary syndrome . METHODS In 20 lean women ( body mass index , 20.0 to 24.4 kg/m 2 ) who had the polycystic ovary syndrome , treatment was initiated with either 600 mg of D-chiro-inositol or placebo orally once daily for 6 to 8 weeks . We performed oral glucose tolerance tests and measured serum sex steroids before and after therapy . To monitor for ovulation , we determined serum progesterone concentrations weekly . RESULTS In the 10 women given D-chiro-inositol , the mean ( + /- st and ard error ) area under the plasma insulin curve after oral administration of glucose decreased significantly from 8,343 + /- 1,149 mU/mL per min to 5,335 + /- 1,792 mU/mL per min in comparison with no significant change in the placebo group ( P = 0.03 for difference between groups ) . Concomitantly , the serum free testosterone concentration decreased by 73 % from 0.83 + /- 0.11 ng/dL to 0.22 + /- 0.03 ng/dL , a significant change in comparison with essentially no change in the placebo group ( P = 0.01 ) . Six of the 10 women ( 60 % ) in the D-chiro-inositol group ovulated in comparison with 2 of the 10 women ( 20 % ) in the placebo group ( P = 0.17 ) . Systolic ( P = 0.002 ) and diastolic ( P = 0.001 ) blood pressures , as well as plasma triglyceride concentrations ( P = 0.001 ) , decreased significantly in the D-chiro-inositol group in comparison with the placebo group , in which these variables either increased ( blood pressure ) or decreased minimally ( triglycerides ) . CONCLUSION We conclude that , in lean women with the polycystic ovary syndrome , D-chiro-inositol reduces circulating insulin , decreases serum and rogens , and ameliorates some of the metabolic abnormalities ( increased blood pressure and hypertriglyceridemia ) of syndrome 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 Background and Aim . Cardiovascular risk is increased in women with menopause and metabolic syndrome . Aim of this study was to test the effect of a new supplement formula , combining cocoa polyphenols , myo-inositol , and soy isoflavones , on some biomarkers of cardiovascular risk in postmenopausal women with metabolic syndrome . Methods and Results . A total of 60 women were enrolled and r and omly assigned ( n = 30 per group ) to receive the supplement ( NRT : 30 mg of cocoa polyphenols , 80 mg of soy isoflavones , and 2 gr of myo-inositol ) , or placebo for 6 months . The study protocol included three visits ( baseline , 6 , and 12 months ) for the evaluation of glucose , triglycerides , and HDL-cholesterol ( HDL-C ) , adiponectin , visfatin , resistin , and bone-specific alkaline phosphatase ( bone-ALP ) . At 6 months , a significant difference between NRT and placebo was found for glucose ( 96 ± 7 versus 108 ± 10 mg/dL ) , triglycerides ( 145 ± 14 versus 165 ± 18 mg/dL ) , visfatin ( 2.8 ± 0.8 versus 3.7 ± 1.1 ng/mL ) , resistin ( 27 ± 7 versus 32 ± 8 µg/L ) , and b-ALP ( 19 ± 7 versus 15 ± 5 µg/mL ) . No difference in HDL-C concentrations nor in adiponectin levels between groups was reported at 6 months . Conclusions . The supplement used in this study improves most of the biomarkers linked to metabolic syndrome . This Trial is registered with NCT01400724 BACKGROUND AND AIMS Prospect i ve studies have demonstrated that the risk of death due to ischaemic heart disease is strongly correlated with blood cholesterol ( TC ) levels . Diet is the basic treatment for all dyslipidaemia . If diet alone proves inadequate , supplements can be used to try to reduce cholesterol levels . These substances are indicated in moderate dyslipidaemia , as they are able to induce a moderate reduction in blood cholesterol . The objective of our study was to investigate the effects of a dietary supplement containing Omega-3 , Policosanol , Resveratrol , L-carnitine , Monascus purpureus , Coenzyme Q10 , Vitamin B6 and Vitamin B12 on TC ( primary end point ) and LDL , triglycerides and HDL ( secondary endpoints ) . PATIENTS AND METHODS The study involved 40 men and 40 women recruited from the outpatient section of our Department r and omly assigned to the treatment group ( A ) or the control group ( B ) . RESULTS There was a statistically significant reduction in TC 6 months after the end of treatment in both groups . In Group A , there was also a statistically significant change in HDL , LDL and TG , while in group B , there was no statistically significant change in HDL , LDL or TG . CONCLUSIONS The dietary supplement used in our study , in combination with a balanced diet and physical exercise , was found to induce a significant reduction in TC and LDL-C and an improvement in HDL-C. In contrast , while a balanced diet together with physical exercise but without the dietary supplement produced a significant reduction in TC , it had no significant effect on the other lipid parameters tested BACKGROUND Obese women with polycystic ovary syndrome ( PCOS ) manifest impaired insulin-stimulated release of a d-chiro-inositol-containing inositolphosphoglycan ( DCI-IPG ) insulin mediator during oral glucose tolerance testing ( OGTT ) , which appears to be restored by the administration of metformin . This suggests that either obesity or PCOS is associated with a defect in the coupling of the stimulation of the insulin receptor by insulin to the release of the DCI-IPG mediator . The objective of this study was to compare the release of bioactive DCI-IPG between normal nonobese women and obese PCOS women during stimulation with two different concentrations of insulin when glucose levels are clamped . METHODS We performed a cross-sectional case-control study at the clinical research center of an academic medical center . A two-step euglycemic-hyperinsulinemic clamp was carried out in 8 nonobese normal and 8 obese PCOS women , during which DCI-IPG bioactivity was monitored . RESULTS At baseline , PCOS women were significantly more obese , hyperinsulinemic , and insulin resistant than the controls . During the clamp studies , DCI-IPG bioactivity increased significantly over the first 45 min of the low-insulin step of the clamp in normal nonobese women ( P = 0.046 ) and then decreased to baseline levels ; DCI-IPG increased again after initiation of the high-insulin step ( P = 0.029 ) . Despite higher insulin levels during the clamp in PCOS women , DCI-IPG bioactivity remained flat throughout both insulin steps and was thus significantly lower than in controls during the initial periods of both steps . CONCLUSIONS The coupling between insulin action and the release of the DCI-IPG mediator is selectively impaired in obese PCOS women , which may contribute to the insulin resistance in these women DESIGN AND PURPOSE The supplemental administration of myo-inositol , D-chiro-inositol , folic acid and manganese ( MDFM ) was tested in a prospect i ve , r and omized , double-blind , placebo controlled clinical trial , pilot study , to test the hypothesis that its supplemental administration in the second trimester of pregnancy would improve glucose and glycemic parameters and blood pressure . SUBJECTS AND METHODS Non-obese uniparous healthy pregnant women between 13th and 24th week of pregnancy were divided into two groups : group I , control group with placebo , and the group II , women in treatment with myo-inositol , D-chiro-inositol , folic acid and manganese . The main outcome measures were the comparative analysis of the parameters analyzed at time 0 , after 30 days and 60 days ; secondary outcome measure was the overall analysis of investigated parameters . RESULTS 24 women were allocated to receive MDFM and 24 the placebo . The two groups did not significantly differ for demographic , lipidic and glycemic parameter and blood pressure . After 30 days , significantly lower cholesterol ( p = 0.0001 ) , significantly lower LDL ( p = 0.0013 ) , lower TG ( p < 0.0001 ) and lower glycemia ( p = 0.0021 ) were observed all favoring group II . No significant difference was observed for HDL , diastolic and systolic blood pressure . After 60 days , significant difference was observed for cholesterol ( p = 0.0001 ) , LDL ( p = 0.0001 ) , HDL ( p = 0.0001 ) , TG ( p = 0.0001 ) , glycemia ( p = 0.0064 ) , all favoring the group treated with M 
    Output:
    