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Efficacy of Pomegranate Seed Powder on Glucose and Lipid Metabolism in Patients with Type 2 Diabetes: A Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial.
Seyed Hashemi, M, Namiranian, N, Tavahen, H, Dehghanpour, A, Rad, MH, Jam-Ashkezari, S, Emtiazy, M, Hashempur, MH
Complementary medicine research. 2021;(3):226-233
Abstract
INTRODUCTION Pomegranate is known as a functional food which has multiple health-promoting activities. It has been assessed for patients with metabolic syndrome. Specifically, an antidiabetic activity of its juice and plausible mechanisms for its action have been shown in multitudinous studies. The aim of this study was assessing the effects of complementary treatment with pomegranate seed powder (PSP) oral supplementation on patients with type 2 diabetes mellitus (T2DM). METHODS Sixty patients were treated for 8 weeks by 5 g PSP or placebo, twice daily. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), total cholesterol, and triglyceride (TG) were recorded as the outcome measures at the beginning and after the intervention. The findings were analyzed using the independent t test and Mann-Whitney U test. RESULTS After 8 weeks, the mean differences of FBG, HbA1c, cholesterol, and TG were significantly decreased in the PSP group when compared with the placebo group (p value <0.05). In addition, post-intervention values of FBG and HbA1c were significantly lower in patients treated with PSP compared to the placebo group (p values = 0.02 and 0.01, respectively). However, the latter comparison regarding cholesterol and TG showed no significant differences (p values = 0.51 and 0.26, respectively). CONCLUSION It seems that complementary treatment with PSP may have beneficial effects on FBG and HbA1c of patients with T2DM. However, its effect on TG and cholesterol was equivocal.
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Green cardamom supplementation improves serum irisin, glucose indices, and lipid profiles in overweight or obese non-alcoholic fatty liver disease patients: a double-blind randomized placebo-controlled clinical trial.
Daneshi-Maskooni, M, Keshavarz, SA, Qorbani, M, Mansouri, S, Alavian, SM, Badri-Fariman, M, Jazayeri-Tehrani, SA, Sotoudeh, G
BMC complementary and alternative medicine. 2019;(1):59
Abstract
BACKGROUND Despite the reported health effects of cardamom on dyslipidemia, hepatomegaly, and fasting hyperglycemia, no human research has studied its potency in non-alcoholic fatty liver disease (NAFLD) as the hepatic part of metabolic syndrome. Our aim was determining the effects of green cardamom (GC) on serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. METHODS The place of participant recruitment was the polyclinic of the National Iranian Oil Company (NIOC) central hospital in Tehran. Based on the ultrasonography and eligibility criteria, 87 participants were randomly divided into two groups as cardamom (n = 43) or placebo (n = 44). The supplementation was two 500 mg capsules 3 times/day with meals for 3 months. Serum irisin, fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) were measured. Quantitative insulin sensitivity check index (QUICKI) and homeostasis model assessment-insulin resistance (HOMA-IR) were also calculated. RESULTS In comparison with placebo, GC significantly increased irisin, HDL-c, and QUICKI and decreased FBI, TG, LDL-c, HOMA-IR, and the grade of fatty liver (P < 0.05). After adjustment for confounders, the changes were similar (P < 0.05) with an exception for LDL-c which had a trend (P = 0.07). The differences in FBS, TC, and body mass index (BMI) were not significant (P > 0.05). CONCLUSION GC supplement improved the grade of fatty liver, serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. The changes in these biomarkers may yield beneficial effects on NAFLD. Further trials on the efficacy of GC for clinical practice are suggested. TRIAL REGISTRATION Iranian Registry of Clinical Trials, IRCT2015121317254N4 . Registered 27/12/2015.
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Kuntai capsules improve glucolipid metabolism in patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.
Liang, R, Liu, Z, Li, P, Fan, P, Xu, L, Sun, X, Peng, J, Peng, X, Zhang, M
Medicine. 2019;(39):e16788
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BACKGROUND The aim of this study was to observe the effect and safety of Heyan Kuntai Capsule (HYKT) on glucose and lipid metabolism in patients with polycystic ovary syndrome (PCOS). METHODS Hundred patients with PCOS were randomly divided into HYKT group (n = 50) and placebo groups (n = 50) in which the individuals were treated with HYKT and its placebo continuously for 6 months. Meanwhile, all participants received health education (such as exercise and diet). The primary outcomes were serum sex hormone levels, a series of blood lipid, fasting and postprandial 2 hours blood glucose. Body mass index (BMI), waist-hip ratio (WHR), insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and insulin-sensitive index (ISI) were also observed. In addition, adverse events were recorded to evaluate the drug safety. RESULTS After treatment, the BMI and WHR of all the patients were decreased. The fasting and postprandial 2 hours blood glucose levels were significantly declined when treated with HYKT, which were not observed in the placebo group. Similarly, serum sex hormones including luteinizing hormone (LH), LH/follicle-stimulating hormone (FSH), and testosterone were lowered after treated with HYKT instead of the placebo. Besides, blood lipids outcomes such as total cholesterol, triglyceride, and low-density lipoprotein cholesterol, as well as insulin and HOMA-IR were decreased with significance in HYKT group when compared with those in the placebo group, whereas high-density lipoprotein cholesterol and ISI increased obviously. CONCLUSION HYKT showed the effect on ameliorating the glucose and lipid metabolism disorder and improving insulin resistance and increase insulin sensitivity of PCOS patients, which is similar to insulin sensitizing agent.
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Effects of Extended-Release Niacin Added to Simvastatin/Ezetimibe on Glucose and Insulin Values in AIM-HIGH.
Goldberg, RB, Bittner, VA, Dunbar, RL, Fleg, JL, Grunberger, G, Guyton, JR, Leiter, LA, McBride, R, Robinson, JG, Simmons, DL, et al
The American journal of medicine. 2016;(7):753.e13-22
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BACKGROUND Niacin is an antidyslipidemic agent that may cause blood sugar elevation in patients with diabetes, but its effects on glucose and insulin values in nondiabetic statin-treated subjects with cardiovascular disease and at high risk for diabetes are less well known. METHODS This was a prespecified, intent-to-treat analysis of the Atherothrombosis Intervention in Metabolic syndrome with low high-density lipoprotein/high triglycerides: Impact on Global Health outcomes trial which randomized 3,414 participants at 92 centers in the US and Canada to extended-release niacin (ERN) plus simvastatin/ezetimibe (ERN) or simvastatin/ezetimibe plus placebo (Placebo). Baseline and annual fasting glucose and insulin values were measured. Those experiencing an adverse event indicative of diabetes or starting medications for diabetes were considered to have confirmed diabetes. In addition, nondiabetic subjects with 2 annual follow-up glucose measurements were categorized into normal, impaired fasting glucose or newly diagnosed diabetes (presumed or confirmed) states. RESULTS Compared with placebo, ERN increased annual fasting glucose from baseline to 1 year in both those with normal (7.9 ± 15.8 vs 4.3 ± 10.3 mg/dL; P < .001) and impaired fasting glucose (4.1 ± 18.7 vs 1.4 ± 14.9; P < .02) and increased insulin levels. Both effects waned over the next 2 years. There were less consistent effects in those with baseline diabetes. There was an increased risk of progressing from normal to presumed or confirmed impaired fasting glucose (ERN 197/336) cases (58.6%) vs placebo 135/325 cases (41.5%; P < .001) over time, but no difference in diabetes development in the 2 treatment groups except in those with normal fasting glucose at baseline. CONCLUSIONS The addition of ERN to simvastatin/ezetimibe had marginal effects on glycemia in those with diabetes at baseline, and there was a trend toward increased development of new-onset diabetes. In addition, ERN increased the risk of developing impaired fasting glucose, which may have deleterious consequences over time and warrants further study.
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Wine grape pomace flour improves blood pressure, fasting glucose and protein damage in humans: a randomized controlled trial.
Urquiaga, I, D'Acuña, S, Pérez, D, Dicenta, S, Echeverría, G, Rigotti, A, Leighton, F
Biological research. 2015;(1):49
Abstract
BACKGROUND The Mediterranean diet is a healthy diet with positive scientific evidence of preventing chronic diseases. Bioactive components support the healthy properties of the Mediterranean diet. Antioxidants and fiber, two components of the Mediterranean diet, are key functional nutrients for healthy eating and nutrition. Wine grape pomace is a rich source of these dietary constituents and may be beneficial for human health. Our hypothesis was that the intake of red wine grape pomace flour (WGPF) prepared from red wine grapes (Cabernet Sauvignon variety) reduced the metabolic syndrome in humans. To evaluate the effect of WGPF on components of metabolic syndrome we design a 16-week longitudinal intervention study. Thirty-eight males, 30-65 years of age, with at least one component of metabolic syndrome, were randomly assigned to either the intervention group (n = 25) or the control group (n = 13). At lunch, the intervention group was given 20 g of WGPF per day, which contained 10 g of dietary fiber, 822 mg of polyphenols and an antioxidant capacity of 7258 ORAC units. Both groups were asked to maintain their regular eating habits and lifestyles. Clinical evaluation, anthropometric measurements and biochemical blood analyses were done at the beginning and the end of the study. RESULTS WGPF intake significantly decreased systolic and diastolic blood pressure as well as fasting glucose levels. Plasma γ-tocopherol and δ-tocopherol increased and carbonyl group in plasma protein decreased in WGPT group, significantly. No significant effect was observed for waist circumference, HDL cholesterol, triglycerides, total antioxidant capacity and vitamin C in and between groups. The group-dependent magnitude of the differences between the baseline and final postprandial insulin values and γ-tocopherol concentrations was statistically significant. CONCLUSIONS The consumption of WGPF-rich in fiber and polyphenol antioxidants, as a food supplement in a regular diet improves blood pressure, glycaemia and postprandial insulin. In addition, increased antioxidant defenses and decreased oxidative protein damage indicating attenuation of oxidative stress. WGPF might be a useful food ingredient for health promotion and chronic disease prevention.
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A randomized intervention trial of 24-wk dairy consumption on waist circumference, blood pressure, and fasting blood sugar and lipids in Japanese men with metabolic syndrome.
Tanaka, S, Uenishi, K, Ishida, H, Takami, Y, Hosoi, T, Kadowaki, T, Orimo, H, Ohashi, Y
Journal of nutritional science and vitaminology. 2014;(5):305-12
Abstract
UNLABELLED Dairy foods are postulated to have beneficial effects on blood pressure, body fat, serum lipids, and the incidence of type 2 diabetes. To evaluate the effects of the consumption of milk and dairy products, we performed a randomized dietary intervention trial for 24 wk in Japanese men, aged 20 to 60 y, with 2 or more components of the metabolic syndrome ( CLINICAL TRIAL REGISTRATION UMIN000006353). Subjects were randomized to a control group (n=98) that received dietary intervention focused on weight control supervised by registered dietitians, and a dairy-consumption group (n=102) that received both dietary intervention and regular home dairy delivery of 400 g/d for 24 wk. Co-primary endpoints included waist circumference, blood pressure, fasting blood sugar (FBS), and serum lipids. The dietary intervention decreased energy intake from 2,150 to 1,850 kcal/d in both groups (p<0.01). Mean rates of compliance with the dairy-consumption intervention were over 90%, resulting in increased calcium intake in the dairy-consumption group from 329 to 667 mg/d (p<0.01). Co-primary endpoints improved in both groups, but the degree of improvement was smaller in the dairy-consumption group (one-sided p=0.99). Subgroup analyses specified in the study protocol identified weight and leisure-time physical activity (LTPA) as significant effect modifiers. Differences in changes in systolic blood pressure compared with the control group were 28.0 mmHg (95% CI, 214.0 to 21.9, interaction; p<0.01) in the normal weight group and 25.8 mmHg (211.4 to 20.2, interaction; p=0.02) in the moderate-to-high LTPA group, indicating lower systolic blood pressure in the dairy-consumption group among participants in these subgroups. In conclusion, although effects on the co-primary endpoints of dairy consumption were not shown, dairy consumption lowered systolic blood pressure in the subgroups with normal weight and moderate-to-high LTPA and lowered FBS in the subgroup with normal weight.
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Metabolic syndrome components and their response to lifestyle and metformin interventions are associated with differences in diabetes risk in persons with impaired glucose tolerance.
Florez, H, Temprosa, MG, Orchard, TJ, Mather, KJ, Marcovina, SM, Barrett-Connor, E, Horton, E, Saudek, C, Pi-Sunyer, XF, Ratner, RE, et al
Diabetes, obesity & metabolism. 2014;(4):326-33
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AIMS: To determine the association of metabolic syndrome (MetS) and its components with diabetes risk in participants with impaired glucose tolerance (IGT), and whether intervention-related changes in MetS lead to differences in diabetes incidence. METHODS We used the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) revised MetS definition at baseline and intervention-related changes of its components to predict incident diabetes using Cox models in 3234 Diabetes Prevention Program (DPP) participants with IGT over an average follow-up of 3.2 years. RESULTS In an intention-to-treat analysis, the demographic-adjusted hazard ratios (95% confidence interval) for diabetes in those with MetS (vs. no MetS) at baseline were 1.7 (1.3-2.3), 1.7 (1.2-2.3) and 2.0 (1.3-3.0) for placebo, metformin and lifestyle groups, respectively. Higher levels of fasting plasma glucose and triglycerides at baseline were independently associated with increased risk of diabetes. Greater waist circumference (WC) was associated with higher risk in placebo and lifestyle groups, but not in the metformin group. In a multivariate model, favourable changes in WC (placebo and lifestyle) and high-density lipoprotein cholesterol (placebo and metformin) contributed to reduced diabetes risk. CONCLUSIONS MetS and some of its components are associated with increased diabetes incidence in persons with IGT in a manner that differed according to DPP intervention. After hyperglycaemia, the most predictive factors for diabetes were baseline hypertriglyceridaemia and both baseline and lifestyle-associated changes in WC. Targeting these cardiometabolic risk factors may help to assess the benefits of interventions that reduce diabetes incidence.
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Changes in visceral adiposity and serum cholesterol with a novel viscous polysaccharide in Japanese adults with abdominal obesity.
Reimer, RA, Yamaguchi, H, Eller, LK, Lyon, MR, Gahler, RJ, Kacinik, V, Juneja, P, Wood, S
Obesity (Silver Spring, Md.). 2013;(9):E379-87
Abstract
OBJECTIVE Evidence supports the role of dietary fiber in improving metabolic health. PolyGlycopleX (PGX), a viscous functional polysaccharide improves lipidemia and glycemia in healthy adults. Our objective was to examine the effects of PGX on risk factors associated with the metabolic syndrome in Japanese adults with abdominal obesity. DESIGN AND METHODS Sixty four subjects assigned to 14 weeks of 15 g day(-1) of PGX or placebo were assessed in a randomized, double-blind, placebo-controlled, parallel group trial. At week 0 and 14, primary outcome measures were serum lipids, abdominal adiposity, glucose tolerance and blood pressure. RESULTS Total and LDL cholesterol were reduced at week 14 with PGX but not placebo (P < 0.05). The reduction in waist circumference at week 14 was greater with PGX versus placebo (P < 0.05). In females, abdominal visceral fat was decreased to a greater extent with PGX versus placebo (P < 0.05). While glucose tolerance worsened with placebo over time, PGX reduced glucose total area under the curve from week 0 to 6 (P = 0.039). Serum concentrations of resistin and IL6 increased slightly in placebo and decreased slightly with PGX . CONCLUSIONS PGX is a functional fiber that shows promise in reducing risk factors related to the metabolic syndrome in Japanese adults with abdominal obesity.
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Comparison of fasting blood sugar and serum lipid profile changes after treatment with atypical antipsychotics olanzapine and risperidone.
Kaushal, J, Bhutani, G, Gupta, R
Singapore medical journal. 2012;(7):488-92
Abstract
INTRODUCTION This study aimed to compare the effects of the two most commonly prescribed atypical antipsychotics, olanzapine and risperidone, on fasting blood sugar and serum lipid profile of the recipients. METHODS A randomised, comparative, open clinical study was conducted on 60 schizophrenic patients. The patients were divided into two groups, one receiving olanzapine and the other receiving risperidone. The patients were assessed for changes in fasting blood sugar and serum lipid profile (triglycerides [TG], high-density lipoprotein [HDL], low-density lipoprotein [LDL], very-low-density lipoprotein [VLDL] and total cholesterol) eight weeks after starting treatment. The number of patients positive for fasting blood sugar and lipid profile criteria of metabolic syndrome was calculated by applying the modified National Cholesterol Education Programme Adult Treatment Panel III guidelines (NCEP ATP III) criteria at eight weeks. RESULTS Patients treated with olanzapine showed a highly significant increase in the observed parameters, whereas those treated with risperidone showed a significant increase in fasting blood sugar, HDL and LDL levels, and a highly significant increase in other parameters. Intergroup comparison was insignificant except for TG, VLDL and total cholesterol levels. More men as compared to women fulfilled the NCEP ATP III criteria for metabolic syndrome in both groups. CONCLUSION Olanzapine has a higher propensity to cause derangement of some parameters of lipid profile than risperidone. These parameters include TG, VLDL and total cholesterol levels.
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Postprandial substrate use in overweight subjects with the metabolic syndrome after isomaltulose (Palatinose™) ingestion.
König, D, Theis, S, Kozianowski, G, Berg, A
Nutrition (Burbank, Los Angeles County, Calif.). 2012;(6):651-6
Abstract
OBJECTIVE Dietary interventions with a low glycemic index have shown to be successful for the prevention and therapy of the metabolic syndrome. In the present study, we investigated the postprandial metabolic response at rest and during physical activity the low glycemic carbohydrate isomaltulose (Palatinose™) intake compared with a conventional carbohydrate (glucose syrup/sucrose [glc/suc]) with a higher glycemic index. METHODS Twenty overweight or obese men (32-64 y old) with the metabolic syndrome and insulin resistance were enrolled in this double-blinded, randomized, cross-over study. In the morning, a breakfast consisting of a 250-mL drink and 140 g of cookies containing in a total of 50 g of Palatinose™ or glc/suc was consumed. Two hours after breakfast, subjects exercised at moderate intensity on a treadmill for 30 min. Thereafter, subjects ingested a standardized lunch consisting of a 250-mL drink with 10% Palatinose™ or glc/suc, mini pizzas, and an apple. RESULTS Blood levels of glucose and insulin were measured and the postprandial substrate metabolism was determined. The glycemic and insulinemic responses were considerably lower after the ingestion of Palatinose™ (incremental area under the curve, P < 0.05). The total fat oxidation was significantly higher with Palatinose™ from breakfast to the beginning of lunch including the exercise and postexercise periods (P < 0.05). Fat oxidation with Palatinose™ was numerically higher throughout the entire examination period (P = 0.09). CONCLUSION In obese subjects with insulin resistance and the metabolic syndrome, the partial substitution of carbohydrates with a higher glycemic index in foods and drinks by Palatinose™ resulted in greater postprandial fat oxidation at rest and during physical activity. It is hypothesized that this increased fat oxidation may confer further benefits for long-term weight management and for an improvement in metabolic risk factors.