Effects of melatonin supplementation in patients with type 2 diabetes mellitus and chronic periodontitis under nonsurgical periodontal therapy: A double-blind randomized controlled trial.

Background: The aim of the present study was to investigate the effects of melatonin supplementation along with nonsurgical periodontal therapy (NSPT) in patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP). Materials and Methods: The present study was a double-blind clinical trial. Fifty diabetic patients with periodontitis were randomly allocated to control (n = 25) and intervention groups (n = 25). Two tablets of 250 mg melatonin (6 mg net melatonin) or placebo were received by the intervention or control groups once a day for 8 weeks. Fasting blood glucose (FBG), glycosylated hemoglobin levels (HbA1c), lipid profile, systolic and diastolic blood pressure (SBP and DBP), anthropometric indices including weight, waist and hip circumference (WC and HC), and body mass index (BMI) were measured in patients at the beginning and end of the intervention. Results: Forty-four patients (22 patients in each group) completed the study. In the intervention group, a significant reduction was observed in HbA1c (P = 0.004), weight, BMI, WC, HC (all P < 0.001), DBP (P = 0.017), and SBP (P = 0.006). The high-density lipoprotein-cholesterol was significantly increased in the intervention group after the intervention (P = 0.007). Moreover, after the adjustment of confounding factors, the mean changes of HbA1c (mean difference: -1.30, confidence interval [CI]: -2.41--0.19, P = 0.02), weight (mean difference: -3.90, CI: -5.30-2.50, P < 0.001), WC (mean difference: -1.37, CI: -2.19--0.55, P = 0.002), BMI (mean difference: -1.41, CI: -1.92--0.89, P < 0.001), HC (mean difference: -3.55, CI: -4.74--2.35, P < 0.001), and SBP (mean difference: -1.24, CI: -2.41--0.06, P = 0.03) improved significantly in the intervention group by comparison with the control group. No side effects were reported during the study. Conclusion: The adjunct therapy of NSPT and melatonin may be useful in controlling the glycemic index, lipid profile, BP, and weight in T2DM with CP.

The Impact of Resveratrol Supplementation on Blood Glucose, Insulin, Insulin Resistance, Triglyceride, and Periodontal Markers in Type 2 Diabetic Patients with Chronic Periodontitis.

The aim of this study was to investigate the impact of resveratrol supplementation along with non-surgical periodontal treatment on blood glucose, insulin, insulin resistance, triglyceride (TG), and periodontal markers in patients with type 2 diabetes with periodontal disease. In this double-blind clinical trial study, 43 patients with diabetes with chronic periodontitis were participated. Subjects were randomly allocated to intervention and control groups. The intervention and control groups received either 480 mg/day of resveratrol or placebo capsules (two pills) for 4 weeks. Fasting blood glucose, insulin, insulin resistance (homeostasis model assessment of insulin resistance), TGs, and pocket depth were measured in all subjects' pre-intervention and post-intervention. The mean serum levels of fasting insulin and insulin resistance (homeostasis model assessment of insulin resistance) were significantly lower in the intervention group compared with control group (10.42 ± 0.28 and 10.92 ± 0.9; 3.66 ± 0.97 and 4.49 ± 1.56, respectively). There was a significant difference in the mean pocket depth between intervention and control groups (2.35 ± 0.6 and 3.38 ± 0.5, respectively) following intervention. No significant differences were observed in the mean levels of fasting blood glucose and TGs between two groups' post-intervention. It is recommended that resveratrol supplementation may be beneficial as adjuvant therapy along with non-surgical periodontal treatment in insulin resistance and improving periodontal status among patients with diabetes with periodontal disease. Copyright © 2016 John Wiley & Sons, Ltd.

Effects of PMS50 supplementation on psychological symptoms of students with premenstrual syndrome.

OBJECTIVE: To evaluate the effects of PMS50 supplementation on psychological symptoms in university students in Iran. METHODS: This double-blind clinical trial was conducted at Ahvaz Jundishapur University of Medical Sciences, between December 2018 and March 2019. Fifty female students with moderate to severe premenstrual syndrome (PMS) randomly received either 550 mg/day of PMS50 (n = 25) or placebo (n = 25), starting from 1 week before till the end of menstruation for three consecutive menstrual cycles. Anthropometric indices, dietary intake, physical activity level, and severity of PMS were assessed at baseline and post-intervention. Data were analyzed by SPSS (version 22). Independent t test was used to compare the results between groups. Paired t test was used to compare the results within groups before and after study. RESULTS: There was a significant improvement in psychological symptoms including depression, anger, feeling of hopelessness, desire to be alone, mood swings, irritability, anxiety, and poor concentration observed in the intervention group compared with the control group post-intervention. Restlessness was significantly reduced in both groups post-intervention. The mean scores of low self-esteem, change in appetite, and food cravings were decreased in both groups, but not significant between groups. CONCLUSION: PMS50 supplementation may be effective in improvement of psychological symptoms in PMS. Clinical Trial Registration No.: IRCT20181218042038 N1.

The Effects of Synbiotic Supplementation on Glycemic Status, Lipid Profile, and Biomarkers of Oxidative Stress in Type 1 Diabetic Patients. A Placebo-Controlled, Double-Blind, Randomized Clinical Trial.

BACKGROUND AND OBJECTIVE: The aim of the present study was to evaluate the effects of synbiotic on glycemic status, lipid profile, and biomarkers of oxidative stress in type 1 diabetes mellitus (T1DM) patients. MATERIALS AND METHODS: In this double-blind clinical trial, 50 T1DM patients were randomly allocated to intervention (n = 25) and control (n = 25) groups and received either synbiotic powder (Lactobacillus sporogenes GBI-30 (probiotic), maltodextrin and fructooligosaccharide (prebiotic)) or placebo 2 g per day for 8 weeks. Fasting blood samples were collected before and after the intervention to measure fasting blood glucose (FBG), insulin concentration, hemoglobin A1c (HbA1c), lipid profile, and biomarkers of oxidative stress such as total antioxidant capacity (TAC) and hs-C-reactive protein (hs-CRP). RESULTS: Supplementation with synbiotic resulted in a significant decrease in the mean serum levels of HbA1c and hs-CRP (p = 0.01 and p = 0.004, respectively), and marginally significant decrease in FBG (p = 0.05) in the intervention group post- intervention. Also, the mean changes of FBG and hs-CRP were significantly lower in the intervention group compared with the control group (p = 0.03 and p = 0.005, respectively). There were no significant changes found in lipid profile in intervention group post-intervention (p≥ 0.05). The mean serum levels of insulin and TAC were significantly increased in the intervention group post-intervention (p = 0.001). There was a significant increase in the mean changes of TAC (p = 0.005) in the intervention group compared with the control group. CONCLUSION: The 8-week synbiotic supplementation in T1DM patients may be effective in improvement of FBG, HbA1c, insulin, hs-CRP, and TAC.

Antioxidant and Anti-Inflammatory Properties of Melatonin in Patients with Type 2 Diabetes Mellitus with Periodontal Disease Under Non-Surgical Periodontal Therapy: A Double-Blind, Placebo-Controlled Trial.

BACKGROUND AND AIM: The imbalance between pro-oxidant and antioxidant systems often leads to further oxidative damage in the pathogenesis of both diabetes and periodontal disease. This study aimed to investigate the antioxidant and anti-inflammatory properties of melatonin in type 2 diabetes mellitus (T2DM) patients with periodontal disease (PD) under non-surgical periodontal therapy (NSPT). MATERIALS AND METHODS: In this double-blind clinical trial study, 50 T2DM patients with PD were randomly allocated to intervention and control groups and received 250 mg/day (2 tablets) either melatonin or placebo 1 h before bedtime for 8 weeks. The NSPT was performed for all patients in both groups at the beginning of the study. The serum levels of interleukin-1b (IL-1b), malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx) were measured pre- and post-intervention. RESULTS: Supplementation with melatonin in adjunct to NSPT significantly increased the serum levels of TAC, SOD, CAT, and GPx in the intervention group (P = 0.02, 0.008, 0.004 and 0.004, respectively). The mean changes of SOD, CAT, and GPx were significantly (P = 0.02, 0.04 and 0.04, respectively) greater in the intervention group compared with the control group. Also, after adjusting for confounding factors, the results did not change in terms of significance (P < 0.05). After the intervention, serum levels of MDA and IL-1b were significantly reduced in the intervention group (P < 0.001 and P = 0.008, respectively). The intervention group exhibited lower mean changes of MDA compared with the control group, and these changes were statistically significant (P = 0.008). In addition, after adjusting for confounding factors, the results did not change in terms of significance. CONCLUSION: The adjunctive effects of melatonin and NSPT may improve inflammatory and antioxidant parameters in T2DM patients with PD.

The Impacts of Synbiotic Supplementation on Periodontal Indices and Biomarkers of Oxidative Stress in Type 2 Diabetes Mellitus Patients with Chronic Periodontitis Under Non-Surgical Periodontal Therapy. A Double-Blind, Placebo-Controlled Trial.

AIM: The aim of the current study was to investigate that combination of the synbiotic supplementation in adjunct with non-surgical periodontal therapy (NSPT) is useful in treating periodontitis and biomarkers of oxidative stress in type 2 diabetes mellitus (T2DM) patients. METHODS: In this study, 47 patients suffering from DM and CP were recruited and randomly assigned to two groups. The intervention (n= 23) and control (n=24) groups received either multispecies probiotic supplement plus 100 mg fructo-oligosaccharide (500 mg in each capsule) or placebo capsule containing 500 mg wheat flour, respectively, every day for 8 weeks. All subjects were treated with NSPT during the intervention period. Serum levels of interleukin-1ß (IL-1ß), malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx) and periodontal indices including clinical attachment loss (CAL), pocket depth (PD) (main outcome), BOP, and plaque index were measured before and after the intervention. RESULTS: Supplementation with the synbiotic with NSPT led to a significant decrease in the levels of IL-1ß, MDA, plaque index, PD, and CAL in the intervention group post-intervention (p < 0.05). The serum levels of TAC, SOD, and GPx were significantly increased in the intervention group compared with the baseline (p < 0.05). Consumption of synbiotic with NSPT, compared to the control, resulted in a significant decrease in the mean changes of IL-1ß, MDA, and CAL (p < 0.05). Also, the mean changes of TAC and GPx were significantly higher in the intervention group compared with the control group (p < 0.05). Also, in the intervention group was seen a significant reduction in plaque index (p = 0.035) and BOP (p = 0.04) compared with the control group. CONCLUSION: It was observed that synbiotic supplementation with NSPT may be beneficial in improving inflammatory, antioxidant, and periodontal status in T2DM patients with CP.

Impact of resveratrol supplementation on inflammatory, antioxidant, and periodontal markers in type 2 diabetic patients with chronic periodontitis.

BACKGROUND: Diabetes mellitus and periodontal disease are two common and chronic diseases with bidirectional relationship influence public health and quality of life. The aims of this study was to study the impact of resveratrol supplementation in adjunct with non-surgical periodontal therapy on inflammatory, antioxidant, and periodontal markers in patients with type 2 diabetes with periodontal disease. MATERIALS AND METHODS: In this randomized clinical trial, 43 patients with diabetes and chronic periodontitis were randomly allocated into two intervention and control groups receiving either resveratrol supplements or placebo for 4 weeks. Serum levels of interleukin 6 (IL6), tumor necrosis factor α (TNFα), total antioxidant capacity (TAC) and clinical attachment loss (CAL) as the main index of periodontal marker were measured pre-intervention and post-intervention. RESULTS: In the intervention group, the mean serum level of IL6 was reduced significantly (P = 0.039) post-intervention (2.19 ±â€¯1.09 and 1.58 ±â€¯1.06). No significant differences were seen in the mean levels of IL6, TNFα, TAC and CAL between two groups post-intervention. CONCLUSIONS: It is suggested that daily consumption of resveratrol supplement may not change TNFα, TAC and CAL, but it would be beneficial in reducing serum levels of IL6. Therefore, further studies are suggested to investigate the effects of resveratrol supplementation along with NST on periodontal status.

The effects of ginger supplementation on inflammatory, antioxidant, and periodontal parameters in type 2 diabetes mellitus patients with chronic periodontitis under non-surgical periodontal therapy. A double-blind, placebo-controlled trial.

BACKGROUND: The aim of this study was to evaluate the effects of ginger supplementation on inflammatory, antioxidant, and periodontal parameters in type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP) under non-surgical periodontal therapy (NSPT). MATERIAL AND METHODS: In this double-blind clinical trial study, 46 T2DM patients with CP were randomly allocated to intervention and control groups and received either 4 tablets 500 mg (2 g) ginger or placebo twice a day for 8 weeks. All patients were treated with NSPT during the intervention period. Serum levels of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), hs-C-reactive protein (hs-CRP), superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx), periodontal indices including clinical attachment loss (CAL), bleeding on probing (BOP), pocket depth (PD), and plaque index were evaluated in all subjects pre- and post-intervention. RESULTS: Following 8 weeks of ginger treatment with NSPT, significant reductions were observed in the mean levels of IL-6 (p=0.001), hs-CRP (p=0.03), TNF-α (p=0.007), CAL, and PD (p<0.001) in the intervention group. The mean serum levels of SOD and GPx were significantly increased in the intervention group after the intervention (p=0.001 and 0.002, respectively). At the end of the study, the mean changes of GPx were significantly higher in the intervention group compared with the control group (p=0.04). Also, after the administration of the ginger with NSPT, significant decrease occurred in the mean change of IL-6 (p=0.009), hs-CRP (p=0.049), TNF-α (p=0.049), CAL (p=0.003), and PD (p=0.04) compared with the control group. CONCLUSION: It is recommended that ginger supplementation along with NSPT may be effective in the improvement of inflammation, oxidative, and periodontal status in T2DM with CP.