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.

99mTc- Anionic dendrimer targeted vascular endothelial growth factor as a novel nano-radiotracer for in-vivo breast cancer imaging.

Since breast cancer is the commonly cause of death among women around the world, diagnosis at the early stages is significantly important to prevent the metastasis of the cancer. Among the various growth factors that are involved in angiogenesis, vascular endothelial growth factor (VEGF) is believed to be the most important factor. Overexpressed VEGF receptor on tumors surface, is particularly interesting for cancer cells targeting purposes. In this study, citric acid dendrimer conjugated with VEGF antagonist peptide was synthesized. The obtained product was confirmed by FT-IR, TEM, DLS, and EDS. In vitro cytotoxicity assay showed no toxicity on normal cells and indicated the notably dose-dependence toxicity on cancer cells. Box-Behnken software as a computational method was used to determine the optimum amount of radiolabeling parameters. Optimized parameters for reducing agent, dendrimer-anti-VEGF, and time were 1.4 mg, 17.5 mg, and about 30 min respectively. Radiochemical purity of radio-labeled conjugated dendrimer was determined about 90 percent. SPECT imaging was done to observe the in vivo accumulation of dendrimer-anti-VEGF in the tumor site. Images showed high accumulation of radio-tracer in the tumor region. All in all, obtained results confirmed our hypothesis that the dendrimer-anti-VEGF can be a good radio-tracer for diagnosis of cancer.

Efficacy of Melissa officinalis L. (lemon balm) extract on glycemic control and cardiovascular risk factors in individuals with type 2 diabetes: A randomized, double-blind, clinical trial.

Melissa officinalis is a plenteous source of antioxidant flavonols and flavonoids that contain health-promoting and antidiabetic properties, so this study was undertaken to provide the first assessment of the antidiabetic properties of hydroalcoholic extract of M. officinalis in type 2 diabetic patients. We did a randomized, placebo-controlled trial which included 62 patients, receiving either M. officinalis capsules (700 mg/d; n = 31) or the placebo (n = 31) twice daily for 12 weeks. There were significant differences in serum FBS (P = 0.007), HbA1c (P = 0.002), ß-cell activity (P = 0.05), TG (P = 0.04), HDL-c (P = 0.05), hs-CRP (P = 0.001), and systolic blood pressure (P = 0.04) between the two groups at the end of the study; but total cholesterol, LDL-c, insulin, and HOMA-IR showed no significant changes between the groups. In M. officinalis group, there was a significant change in HDL-c (P = 0.009) and QUICKI (P = 0.005) compared with baseline values. No adverse effects were observed. It seems that M. officinalis is safe and effective in improvement of lipid profile, glycemic control, and reduction of inflammation.

Safety and efficacy of Melissa officinalis (lemon balm) on ApoA-I, Apo B, lipid ratio and ICAM-1 in type 2 diabetes patients: A randomized, double-blinded clinical trial.

BACKGROUND: The purpose of this study was to investigate the safety and effects of Melissa officinalis, a good source of bioactive components, on apolipoprotein (Apo)B, Apo A-I, and their ratio, lipids ratios and intercellular adhesion molecule-1(ICAM-1) in patients with type 2 diabetes. METHODS: For the present randomized, double-blinded, placebo-controlled clinical trial, 70 type 2 diabetic patients aged 20-65 years old were randomly assigned to receive hydroalcoholic extract of M. officinalis (HEMO) (700 mg/d) or placebo twice-daily for 12 weeks. RESULTS: There were significant differences in serum Apo A-I, TC/ HDL-c and LDL-c/ HDL-c between the two groups at the end of the study (p < 0.05), but we did not show significant differences in the values for Apo B, Apo B/Apo A-I, TG/HDL-c, ICAM-1 and liver enzymes include AST, ALT, and ALP between the study groups. Although both groups showed a significant reduction in ICAM-1, AST and, ALP (p < 0.05), no significant differences in ICAM-1, AST and, ALP were observed. At end, in M. officinalis group, there was a significant increase in Apo A-I (p = 0.003) and significant reduction in TG/HDL-c (p = 0.05) compared with initial values, as well as in placebo group, there was a significant rising in Apo B/Apo A-I (p = 0.02) and significant reduction in Apo A-I (p = 0.001) compared with baseline values. CONCLUSIONS: M. officinalis is safe and effective in improvement of Apo A-I, Apo B/Apo A-I, and lipids ratios as key factors promoting cardiovascular disease (CVD) in type II diabetic patients.

Synthesis and characterization of insulin/zirconium phosphate@TiO2 hybrid composites for enhanced oral insulin delivery applications.

In this work, a series of composites of insulin (Ins)/zirconium phosphate (ZrP) were synthesized by intercalation method, then, these composites were coated with TiO2 by sol-gel method to prepare Ins/ZrP@TiO2 hybrid composites and the drug release of the composites was investigated by using UV-Vis spectroscopy. Ins/ZrP (10, 30, 60 wt%) composites were prepared by intercalation of insulin into the ZrP layers in water. Then Ins/ZrP composites were coated with different amounts of TiO2 (30, 50, 100 wt %) by using titanium tetra n-butoxide, as precursor. Formation of intercalated Ins/ZrP and Ins/ZrP@TiO2 hybrid composites was characterized by FT-IR, FE-SEM, BET and XRD analysis. Zeta potential of the optimized Ins/ZrP@TiO2 hybrid composite was determined -27.2 mV. Cytotoxic effects of the optimized Ins/ZrP@TiO2 hybrid composite against HeLa and Hek293T cell lines were evaluated using MTT assay and the results showed that designed drug delivery system was not toxic in biological environment. Compared to the Ins/ZrP composites, incorporation of TiO2 coating enhanced the drug entrapment considerably, and reduced the drug release. The Ins/ZrP composites without TiO2 coating released the whole drug after 30 min in pH 7.4 (phosphate buffer solution) while the TiO2-coated composites released the entrapped drug after 20 h. In addition to increasing the shelf life of hormone, this nanoencapsulation and nanocoating method can convert the insulin utilization from injection to oral and present a painless and more comfortable treatment for diabetics.