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The investigation was done to assess the impacts of probiotic supplementation on movement and metabolic parameters in individuals with Parkinson's disease (PD). The study is randomized, double-blind, placebo-controlled clinical trial, which was done in sixty people with PD. Individuals were randomly divided into two groups in order to take either 8 × 109 CFU/day probiotic or placebo (n = 30 each group) that lasted 12 weeks. The Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was recorded at pre- and post-intervention. Compared with the placebo, consuming probiotic decreased MDS-UPDRS (−4.8 ± 12.5 vs. +3.8 ± 13.0, P = 0.01). Probiotic supplementation also reduced high-sensitivity C-reactive protein (−1.6 ± 2.5 vs. +0.1 ± 0.3 mg/L, P < 0.001) and malondialdehyde (−0.2 ± 0.3 vs. +0.1 ± 0.3 μmol/L, P = 0.006), and enhanced glutathione levels (+40.1 ± 81.5 vs. −12.1 ± 41.7 μmol/L, P = 0.03) in comparison with the placebo. Additionally, probiotic consumption resulted in a statistically significant reduction in insulin levels (−2.1 ± 3.4 vs. +1.5 ± 5.1 μIU/mL, P = 0.002) and insulin resistance (−0.5 ± 0.9 vs. +0.4 ± 1.2, P = 0.002), and a statistically significant rise in insulin sensitivity (+0.01 ± 0.02 vs. −0.006 ± 0.02, P = 0.01) in comparison with the placebo. Probiotic intake had no any significant impact on other metabolic profiles. Our study evidenced that 12 weeks of probiotic consumption by individuals with PD had useful impacts on MDS-UPDRS and few metabolic profiles. Registered under ClinicalTrials.gov Identifier no. http://www.irct.ir : IRCT2017082434497N4. [ABSTRACT FROM AUTHOR]

Summary Background & aims Melatonin may benefit diabetic people with coronary heart disease (CHD) through its beneficial effects on biomarkers of oxidative stress and cardio-metabolic risk. This investigation evaluated the effects of melatonin administration on metabolic status in diabetic patients with CHD. Methods This randomized, double-blind, placebo-controlled trial was conducted and involved 60 diabetic patients with CHD. Subjects were randomly allocated into two groups to receive either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day for 12 weeks. Results Compared with the placebo, melatonin supplementation resulted in significant increases in plasma glutathione (GSH) (+64.7 ± 105.7 vs. −11.1 ± 137.6 μmol/L, P = 0.02) and nitric oxide (NO) (+0.9 ± 4.7 vs. −3.3 ± 9.6 μmol/L, P = 0.03), and significant decreases in malondialdehyde (MDA) (−0.2 ± 0.3 vs. +0.1 ± 0.5 μmol/L, P = 0.007), protein carbonyl (PCO) (−0.12 ± 0.08 vs. +0.03 ± 0.07 mmol/mg protein, P < 0.001) and serum high sensitivity C-reactive protein (hs-CRP) levels (−1463.3 ± 2153.8 vs. +122.9 ± 1230.4 ng/mL, P = 0.001). In addition, taking melatonin, compared with the placebo, significantly reduced fasting plasma glucose (−29.4 ± 49.0 vs. −5.5 ± 32.4 mg/dL, P = 0.03), serum insulin concentrations (−2.2 ± 4.1 vs. +0.7 ± 4.2 μIU/mL, P = 0.008), homeostasis model of assessment-estimated insulin resistance (−1.0 ± 2.2 vs. +0.01 ± 1.6, P = 0.04), total-/HDL-cholesterol ratio (−0.18 ± 0.38 vs. +0.03 ± 0.35, P = 0.02) and systolic (−4.3 ± 9.6 vs. +1.0 ± 7.5 mmHg, P = 0.01) and diastolic blood pressure (−2.8 ± 7.3 vs. +0.1 ± 3.6 mmHg, P = 0.04). Melatonin treatment also significantly increased quantitative insulin sensitivity check index (+0.006 ± 0.01 vs. −0.004 ± 0.01, P = 0.01) and serum HDL-cholesterol (+2.6 ± 5.5 vs. −0.01 ± 4.4 mg/dL, P = 0.04). Supplementation with melatonin had no significant effect on other metabolic parameters. Conclusions Overall, melatonin intake for 12 weeks to diabetic patients with CHD had beneficial effects on plasma GSH, NO, MDA, PCO, serum hs-CRP levels, glycemic control, HDL-cholesterol, total-/HDL-cholesterol ratio, blood pressures and parameters of mental health. Registered under ClinicalTrials.gov Identifier no. http://www.irct.ir : IRCT2017051333941N1. [ABSTRACT FROM AUTHOR]

Summary Background & aims This trial was performed to evaluate the effects of probiotic intake on disability, mental health and metabolic condition in subjects with multiple sclerosis (MS). Methods This randomized double-blind placebo-controlled clinical trial was conducted among 60 MS patients. Participants were randomly allocated into two groups to receive either a probiotic capsule (n = 30) or placebo containing starch (n = 30) for 12 weeks. Expanded disability status scale (EDSS) scoring and parameters of mental health were recorded at the baseline and 12 weeks after the intervention. Results Compared with the placebo, probiotic intake improved EDSS (−0.3 ± 0.6 vs. +0.1 ± 0.3, P = 0.001), beck depression inventory (−5.6 ± 4.9 vs. −1.1 ± 3.4, P < 0.001), general health questionnaire (−9.1 ± 6.2 vs. −2.6 ± 6.4, P < 0.001) and depression anxiety and stress scale (−16.5 ± 12.9 vs. −6.2 ± 11.0, P = 0.001). In addition, changes in high-sensitivity C-reactive protein (−1.3 ± 3.5 vs. +0.4 ± 1.4 μg/mL, P = 0.01), plasma nitric oxide metabolites (+1.0 ± 7.9 vs. −6.0 ± 8.3 μmol/L, P = 0.002) and malondialdehyde (MDA) (+0.009 ± 0.4 vs. +0.3 ± 0.5 μmol/L, P = 0.04) in the probiotic group were significantly different from the changes in these parameters in the placebo group. Additionally, the consumption of probiotic capsule significantly decreased serum insulin (−2.9 ± 3.7 vs. +1.1 ± 4.8 μIU/mL, P < 0.001), homeostasis model of assessment-estimated insulin resistance (−0.6 ± 0.8 vs.+0.2 ± 1.0, P = 0.001), Beta cell function (−12.1 ± 15.5 vs. +4.4 ± 17.5, P < 0.001) and total-/HDL-cholesterol (−0.1 ± 0.3 vs.0.1 ± 0.3, P = 0.02), and significantly increased quantitative insulin sensitivity check index (+0.01 ± 0.02 vs. −0.005 ± 0.01, P < 0.001) and HDL-cholesterol levels (2.7 ± 3.4 vs. 0.9 ± 2.9 mg/dL, P = 0.02) compared with the placebo. Conclusions Our study demonstrated that the use of probiotic capsule for 12 weeks among subjects with MS had favorable effects on EDSS, parameters of mental health, inflammatory factors, markers of insulin resistance, HDL-, total-/HDL-cholesterol and MDA levels. [ABSTRACT FROM AUTHOR]

Summary Background & aims This study was carried out to evaluate the effects of omega-3 fatty acid administration on markers of insulin resistance, lipid concentrations, biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy (DN). Methods This parallel randomized double-blind placebo-controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 1000 mg/day omega-3 fatty acid from flaxseed oil (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at the onset of the study and 12 weeks after supplementation to assess glycaemic status, lipid concentrations, biomarkers of inflammation and oxidative stress. Results After 12 weeks of treatment, patients who consumed omega-3 fatty acid supplements compared with the placebo had significantly decreased serum insulin levels (−39.6 ± 10.8 vs. −7.2 ± 8.4 pmol/L, P = 0.001), homeostasis model of assessment-estimated b cell function (HOMA-B) (−30.2 ± 11.2 vs. −1.5 ± 6.8, P = 0.03) and improved quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.004 vs. +0.002 ± 0.004, P = 0.03). Additionally, compared with the placebo, omega-3 fatty acid administration led to a significant reduction in serum triglycerides (−19.8 ± 8.8 vs. +12.6 ± 10.2 mg/dL, P = 0.01) and VLDL-cholesterol concentrations (−4.0 ± 1.8 vs. +2.5 ± 2.0 mg/dL, P = 0.01). Supplementation with omega-3 fatty acid had no significant effects on other lipid subfractions, biomarkers of inflammation and oxidative stress compared with the placebo. In addition, within-group differences revealed significant reductions in serum insulin (P = 0.001), HOMA-IR (P = 0.004), HOMA-B (P = 0.01), serum triglycerides (P = 0.03), VLDL- (P = 0.03), total- (P < 0.001), LDL- (P = 0.002), total-/HDL-cholesterol ratio (P = 0.001), blood urea nitrogen (P = 0.04), and significant increases in QUICKI (P = 0.001) and nitric oxide (P = 0.005) and total antioxidant capacity concentrations (P = 0.02) in the omega-3 fatty acid group. Conclusions Our findings indicated that omega-3 fatty acid administration for 12 weeks among DN patients had favorable effects on insulin levels, HOMA-B, QUICKI, serum triglycerides and VLDL-cholesterol; however, it did not influence biomarkers of inflammation and oxidative stress. [ABSTRACT FROM AUTHOR]

Summary Background & aims Few studies have examined the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations in overweight and obese vitamin D deficient women with polycystic ovary syndrome (PCOS). This study was conducted to determine the effects of calcium plus vitamin D supplementation on glucose metabolism and lipid concentrations among overweight and obese vitamin D deficient women with PCOS. Methods This randomized double-blind placebo-controlled clinical trial was conducted among 104 overweight and obese vitamin D deficient women diagnosed with PCOS. Participants were randomly assigned into four groups to receive: 1) 1000 mg/d calcium + vitamin D placebo ( n = 26); 2) 50,000 IU/wk vitamin D + calcium placebo ( n = 26); 3) 1000 mg calcium/d + 50,000 IU/wk vitamin D ( n = 26) and 4) calcium placebo + vitamin D placebo ( n = 26) for 8 weeks. Fasting blood samples were taken at baseline and after 8 weeks' intervention to measure glucose metabolism and lipid concentrations. Results Calcium-vitamin D co-supplementation resulted in higher levels of serum calcium ( P = 0.002) and vitamin D ( P < 0.001) compared with other groups. Co-supplementation, compared with other groups, led to decreased serum insulin levels ( P = 0.03), homeostasis model of assessment-insulin resistance (HOMA-IR) score ( P = 0.04) and a significant rise in quantitative insulin sensitivity check index (QUICKI) ( P = 0.001). Furthermore, a significant decrease in serum triglycerides ( P = 0.02) and VLDL-cholesterol levels ( P = 0.02) was seen following the administration of calcium plus vitamin D supplements compared with the other groups. Co-supplementation with calcium and vitamin D had no significant effects on FPG, total-, LDL-, HDL-, and non-HDL-cholesterol levels. Conclusions In conclusion, calcium plus vitamin D supplementation for eight weeks among vitamin D deficient women with PCOS had beneficial effects on serum insulin levels, HOMA-IR, QUICKI, serum triglycerides and VLDL-cholesterol levels, but it did not affect FPG and other lipid profiles. Clinical registration number www.irct.ir : IRCT201309275623N10 [ABSTRACT FROM AUTHOR]