Eryngium billardieri extract affects cardiac gene expression of master regulators of cardiomyaopathy in rats with high fatdiet-induced insulin resistance.

BACKGROUND: For years, numerous studies have focused on identifying approaches to increase insulin sensitivity by modifying the signaling factors. In the present study, we examined the effects of Eryngium billardieri extract, as an anti-diabetic herbal medication, on the heart mRNA level of Akt serine/threonine kinase (Akt), mechanistic target of rapamycin kinase (mTOR), peroxisome proliferator-activated receptor gamma (PPARγ), and Forkhead box o1 (Foxo1) in rats with high-fat diet (HFD)-induced insulin resistance (IR). We also assessed the anti-diabetic effects of E. billardieri extract in rats with insulin resistance. METHODS: Twenty-seven male Wistar rats were divided into two groups. Nine rats were fed a normal diet (control group), and 18 rats were fed an HFD for 13 weeks (HFD group). To confirm the induction of insulin resistance, the oral glucose tolerance test (OGTT) was performed and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated. Then rats with IR were randomly divided into the following groups: the HFD group, which continued an HFD, and the group treated with E. billardieri extract, which received the extract at a concentration of 50 mg/kg for 30 days. On the 30th day, the animals were sacrificed and serum samples were collected for biochemistry analyses. Furthermore, the expression of Akt, mTOR, PPARγ, and Foxo1 was measured in heart tissue using the real-time polymerase chain reaction (PCR) method. RESULTS: Real-time PCR analyses revealed that an HFD can significantly decrease the expression level of Akt, mTOR, and PPARγ in the heart tissue. However, an HFD significantly increased the expression level of Foxo1 in the HFD group compared to the control group (P < 0.05). In addition, our data showed that the administration of E. billardieri extract significantly enhanced the mRNA levels of Akt, PPARγ, and mTOR in the heart tissue compared to the HFD group (P < 0.05), while it significantly decreased the Foxo1 mRNA levels (P < 0.01). CONCLUSION: Given that Akt, mTOR, PPARγ, and Foxo1 are critical factors in insulin resistance, the present study suggests that E. billardieri could probably be used as an alternative treatment for IR as a major feature of metabolic syndrome.

The effects of melissa officinalis on depression and anxiety in type 2 diabetes patients with depression: a randomized double-blinded placebo-controlled clinical trial.

BACKGROUND: Depression is more common in diabetic patients, with a 1.5-fold increased risk of death.Melissa officinalis (M. officinalis) have anti-diabetic and anti-depression activities. The study aimed to determine the efficacy of M. officinalis extract on depression, anxiety, and sleep quality in patients with type 2 diabetes with depressive symptoms. METHODS: In this double-blind clinical trial, 60 volunteer patients (age range 20-65 years) with type 2 diabetes mellitus with symptoms of depression were randomized into the intervention (received 700 mg/day hydroalcoholic extract; n = 30) or control group (received 700 mg/day toasted flour; n = 30). Dietary intake, physical activity, anthropometric indices, FBS (Fasting blood sugar), hs-CRP(High-sensitivity C-reactiveprotein), depression, anxiety, and sleep quality were determined at the beginning and end of the study. Depression and anxiety were assessed by Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI), respectively; sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). RESULTS: Sixty participants received M. officinalis extract or placebo, of which 44 patients completed the 12-week double-blind clinical trial. After 12-week the mean change of depression and anxiety scores were statistically significant between the two groups (p < 0.001 and p = 0.04, respectively), but no significant differences were observed in FBS, hs-CRP, anthropometric indices, sleep quality, and blood pressure.In the intervention group, there was a significant decrease in depression and anxiety severity(p < 0.001 and p = 0.01, respectively) at the end of the study compared to the baseline. TRIAL REGISTRATION: All protocols in this study were followed in accordance with the Helsinki Declaration (1989 revision). Ethical approval for this study was obtained from the Iran University of Medical Sciences Ethics committee (IR.IUMS.FMD.REC 1396.9413468004; research.iums.ac.ir). The study was registered at the Iranian Registry of Clinical Trials (IRCT201709239472N16); Registration date: 09/10/2017.

Efficacy and safety of oral Nigella sativa oil for symptomatic treatment of knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND AND PURPOSE: The oil of Nigella sativa (NS) seeds has analgesic and anti-inflammatory effects. Therefore, the efficacy and safety of NS oil in the treatment of knee osteoarthritis were evaluated. MATERIALS AND METHODS: One hundred and sixteen patients aged 50-70 years were randomly assigned to take 2.5 mL NS oil (N = 58) or placebo (N = 58) orally every 8 h for 1 month. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) was the primary outcome measure and Visual Analog Scale (VAS) for pain, number of 500 mg acetaminophen tablets taken per day during the trial, patients' satisfaction with the interventions, complete blood count and the blood levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine and blood urea nitrogen were the secondary outcome measures. RESULTS: Fifty two and 54 patients respectively in the NS oil and placebo groups completed the study. The VAS scores were decreased by 33.96 ± 17.04% (NS oil group) and 9.21 ± 0.32% (placebo group) (p < 0.001), and WOMAC total scores were decreased by 27.72 ± 18.61% (NS oil group) and 1.34 ± 2.31% (placebo group) (p < 0.001) compared to baseline. The NS oil reduced the dose of acetaminophen significantly compared with the placebo (p = 0.001). The patients were significantly more satisfied with the NS oil than the placebo (p < 0.001). The NS oil had no significant effect on the other variables. There was no side effect. CONCLUSION: Oral NS oil safely reduces the osteoarthritis symptoms and analgesic dose in the knee osteoarthritis patients.

Efficacy and Safety of a Traditional Herbal Combination in Patients with Type II Diabetes Mellitus: A Randomized Controlled Trial.

BACKGROUND: Capparis spinosa, Rosa canina, Securidaca securigera, Silybum marianum, Urtica dioica, Trigonella foenum-graecum and Vaccinium arctostaphylos are used traditionally as an herbal combination for treatment of diabetic patients in Iran. Despite the clinical evidence supporting their use in solitary form, no controlled human study has determined the efficacy and safety of their combination in treatment of diabetic patients. METHODS: A total 150 type II diabetic patients of both sexes under the oral anti-hyperglycemic drugs treatment (maximum 10 mg glyburide and 1000 mg metformin daily) were randomly assigned to three groups. The patients in each group received either herbal combination or placebo or metformin capsule daily for three months, without any change in their previous oral anti-hyperglycemic drugs dosage. Herbal combination, placebo and metformin capsules matched by shape and color were prepared in the Institute of Medicinal Plants Karaj, Iran. To assess the efficacy and safety of the treatments, the patients fasting plasma glucose, HbA1c, lipid profile, liver enzymes and renal function were determined at the beginning of the study and after three months. RESULTS: Results showed that after three months, the fasting plasma glucose, HbA1c and cholesterol levels in herbal combination were decreased significantly as compared to placebo group (20% and 12% respectively) and also compared to base line (25% and 15% respectively). The herbal combination was as effective as metformin in reduction of FPG (p = 0.001, p = 0.001) and HbA1c (p = 0.028 and p = 0.050 respectively) compared to placebo. No notable hepatic, renal and gastrointestinal side effects were observed in the trial groups. CONCLUSION: The results suggest that traditional herbal combination may safely improve glycemic control in type II diabetic patients with no significant adverse effect. [Formula: see text].

Effects of probiotic, cinnamon, and synbiotic supplementation on glycemic control and antioxidant status in people with type 2 diabetes; a randomized, double-blind, placebo-controlled study.

PURPOSE: The aim of this study was to investigate the effect of probiotic bacteria of Lactobacillus acidophilus, cinnamon powder and their combinations on the glycemic and antioxidant indices in patients with type 2 diabetes. METHODS: A total of 136 patients randomized with type 2 diabetes entered the study and were randomly divided into four groups who were matched for age and gender. Thereafter, alongside their routine pharmacotherapy, each group followed one of the following diets: Group A: Lactobacillus acidophilus 108 cfu and 0.5 g of powdered cinnamon (synbiotic). Group B: Lactobacillus acidophilus (probiotic), Group C: powdered cinnamon. Group D: rice flour powder as placebo. At the beginning and end of the intervention, fasting blood sugar (FBS), HbA1c, advance glycation end products (AGE), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and antioxidant enzymes of superoxide dismutase (SOD), glutathione peroxidase (GPx) and catalase (CAT) were measured. RESULTS: Following 3 months of treatment, the mean FBS level was decreased significantly in probiotic, cinnamon, and synbiotic supplementation groups compared with control (P < 0.01). FBS levels in probiotic, cinnamon, and synbiotic groups were significantly decreased compared with the control group (P = 0.001, P = 0.063 and P = 0.001, respectively). The mean HbA1C in probiotic, cinnamon, and synbiotic groups were also decreased (P = 0.001, P = 0.001 and P = 0.04, respectively). The mean AGE in synbiotic group was significantly decreased (P = 0.037). Probiotic, cinnamon and synbiotic all could improve antioxidant enzyme activity modestly. However, the most significant effect was seen in probiotic group. CONCLUSIONS: According to the current results, the use of probiotic supplements (individually or in combination with cinnamon) leads to a reduction in blood glucose and an increase in antioxidant enzymes in people with type 2 diabetes.

Standardized Nigella sativa seed oil ameliorates hepatic steatosis, aminotransferase and lipid levels in non-alcoholic fatty liver disease: A randomized, double-blind and placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL EVIDENCE: Nigella sativa (N. sativa) seeds are used in the Iranian traditional medicine for the treatment of liver diseases. AIM OF STUDY: To study the efficacy and safety of N. sativa seed oil in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). MATERIALS AND METHODS: Sixty patients received 2.5 mL fully standardized N. sativa seed oil every 12 h and 60 other patients received placebo for 3 months. At the baseline and endpoint, hepatic steatosis ultrasound grade and blood levels of triglycerides, LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol), ALT (alanine aminotransferase), AST (aspartate aminotransferase), blood urea nitrogen, creatinine and complete blood cell count as well as body mass index were determined in the oil and placebo groups and compared. RESULTS: Grade of hepatic steatosis was significantly reduced in the oil group compared to the placebo group (P = 0.004). Mean ±â€¯standard deviation of changes of variables in the oil and placebo groups were respectively 32.6 ±â€¯16.6 and 14.2 ±â€¯19.7% for ALT (P < 0/001), 29.4 ±â€¯16.3 and 12.3 ±â€¯16.8% for AST (P < 0.001), 10 ±â€¯13.9 and 0.22 ±â€¯18.2% for triglycerides (P = 0.001), 14.1 ±â€¯9.8 and 9.2 ±â€¯11.1% for LDL-C (P = 0.01), 9.5 ±â€¯7.7 and 4.8 ±â€¯6.5% for HDL-C (P = 0.001). However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05). No adverse effect was observed. CONCLUSIONS: The N. sativa seed oil seems to be safe and improve liver steatosis and injury and blood levels of triglycerides, LDL-C and HDL-C in the NAFLD patients.

The Effects of Boswellia serrata Gum Resin on the Blood Glucose and Lipid Profile of Diabetic Patients: A Double-Blind Randomized Placebo-Controlled Clinical Trial.

Regarding preclinical evidence for antidiabetic effects of Boswellia serrata, we evaluated antihyperglycemic and lipid-lowering effects of Boswellia serrata gum resin in type 2 diabetic patients. Fifty-six diabetic patients were randomly allocated to 2 groups to receive 250 mg of the Boswellia serrata gum resin or placebo twice daily for 8 weeks in addition to their routine antidiabetic treatments. Although there was a considerable reduction after the intervention in the field of fasting blood sugar, glycosylated hemoglobin, and triglyceride in the Boswellia serrata gum resin group, no significant difference was observed in all outcome measures between the 2 groups at the end of the study. The current study showed that 8 weeks of complementary use of Boswellia serrata gum resin with a daily dose of 500 mg had no better glucose and lipid-lowering effect than placebo in diabetic patients.

Silymarin, Olibanum, and Nettle, A Mixed Herbal Formulation in the Treatment of Type II Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

Silybum marianum (L) Gaertn (milk thistle) seeds, Urtica dioica L (nettle) leaves, and Boswellia serrata (olibanum gum) resin are used traditionally by Iranian diabetic patients. The aim of this study was to evaluate the antihyperglycemic effects of these herbs in an herbal formulation in patients with type II diabetes mellitus. Sixty patients diagnosed as type II diabetes mellitus with fasting blood glucose level from 150 to 180 mg/dL, glycosylated hemoglobin level from 7.5% to 8.5%, and on oral antihyperglycemic drugs, were allocated to receive the mix herbal formulation or placebo for 90 days in a double-blind randomized placebo-controlled clinical trial. The mean serum fasting blood glucose, glycosylated hemoglobin, and triglyceride in the herbal drug group were significantly less than placebo group's values after 3 months of the intervention. The study showed a potential antihyperglycemic and triglyceride lowering effect of the herbal formulation, while it did not have any significant cholesterol or blood pressure lowering effect.

Effects of an Herbal Combination on Glycemic Control and Lipid Profile in Diabetic Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

The present study was conducted to explore the efficacy and safety of a herbal combination in the treatment of women with hyperlipidemic type 2 diabetes. The herbal combination capsule (600 mg) contained Terminalia chebula fruit extract (200 mg), Commiphora mukul (200 mg), and Commiphora myrrha oleo-gum-resin (200 mg), and the placebo capsule contained 600 mg toast powder. The patients in one group took the herbal combination and those in the other group took placebo capsules 3 times a day for 3 months. In the herbal combination-treated patients, the fasting blood glucose, total cholesterol, and low-density lipoprotein cholesterol levels were decreased and hidh-density lipoprotein cholesterol levels was increased significantly at the endpoint compared with the placebo and baseline. Other blood parameters such as glycosylated hemoglobin, triglyceride, blood urea nitrogen, creatinine, SGOT, and SGPT levels were not significantly changed after 3 months in both groups. In conclusion, the herbal combination improves glycemic control and lipid profile in women with hyperlipidemic type 2 diabetes without any adverse events.

The Efficacy of Boswellia Serrata Gum Resin for Control of Lipid Profile and Blood Glucose in Diabetic Patients.

BACKGROUND: Regarding preclinical evidence for antidiabetic effects of Boswellia serrata, we evaluated anti-hyperglycemic and lipid-lowering effects of Boswellia serrate gum resin in type 2 diabetic patients in a double-blind randomized placebo-control trial. METHODS: Fifty-six diabetic patients were randomly allocated to two groups to receive 250 mg of the Boswellia serrate gum resin or placebo twice daily for 8 weeks, in addition to their routine antidiabetic treatments. Fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), insulin level, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglyceride of serum were measured before and after the intervention. RESULTS: Although there was a considerable reduction after the intervention in FBS (P=0.04), HbA1c (P=0.02) and triglyceride (P=0.01) in the Boswellia serrate gum resin group, no significant difference was observed in all outcome measures between the two groups at the end of the study (FBS P=0.09, HbA1c P=0.20, total cholesterol P=0.31, LDL P=0.49, HDL P=0.10, triglyceride P=0.78 and insulin level P=0.86). CONCLUSION: The current study showed the 8 weeks complementary use of Boswellia serrate gum resin with a daily dose of 500 mg had no better glucose and lipid lowering effect than placebo in diabetic patients.