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Background: The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with PCOS. Data on the effects of selenium and probiotic co-supplementation on mental health, hormonal and inflammatory parameters of patients with polycystic ovary syndrome (PCOS) are scarce. This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health, hormonal and inflammatory parameters in women with PCOS., Methods: This randomized, double-blinded, placebo-controlled clinical trial was conducted on 60 subjects, aged 18-40 years old. Participants were randomly allocated into two groups to intake 8 × 10 9  CFU/day probiotic plus 200 μg/day selenium supplements (n = 30) or placebo (n = 30) for 12 weeks. Hormonal and inflammatory parameters were measured at baseline and after the 12-week intervention., Results: Probiotic and selenium co-supplementation resulted in a significant improvement in beck depression inventory (β - 0.76; 95% CI, - 1.26, - 0.26; P = 0.003), general health questionnaire scores (β - 1.15; 95% CI, - 1.97, - 0.32; P = 0.007) and depression anxiety and stress scale scores (β - 1.49; 95% CI, - 2.59, - 0.39; P = 0.009) compared with the placebo. Furthermore, probiotic and selenium co-supplementation significantly reduced total testosterone (β - 0.26 ng/mL; 95% CI, - 0.51, - 0.02; P = 0.03), hirsutism (β - 0.43; 95% CI, - 0.74, - 0.11; P = 0.008), high-sensitivity C-reactive protein (hs-CRP) (β - 0.58 mg/L; 95% CI, - 0.97, - 0.19; P = 0.004) and malondialdehyde (MDA) levels (β - 0.29 μmol/L; 95% CI, - 0.56, - 0.02; P = 0.03), and significantly increased total antioxidant capacity (TAC) (β + 84.76 mmol/L; 95% CI, + 48.08, + 121.44; P < 0.001) and total glutathione (GSH) levels (β + 26.78 μmol/L; 95% CI, + 4.33, + 49.23; P = 0.02) compared with the placebo., Conclusions: Overall, the co-administration of probiotic and selenium for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, TAC, GSH and MDA levels. This study was prospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( http://www.irct.ir : IRCT20170513033941N22)., Trial Registration: IRCT20170513033941N22 .

Background: Combined omega-3 fatty acid and vitamin D supplementation may improve multiple sclerosis (MS) by correcting metabolic abnormalities and attenuating oxidative stress and inflammation., Objective: This study aimed to determine the effects of ω-3 fatty acid and vitamin D cosupplementation on the disability score and metabolic status of patients with MS., Methods: This was a randomized, placebo-controlled clinical trial with Expanded Disability Status Scale (EDSS) score and inflammation as primary outcomes and oxidative stress biomarkers and metabolic profile as secondary outcomes. Patients, aged 18-55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n = 53) and randomly received a combined 2 × 1000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo for 12 wk. The placebos were matched in colour, shape, size, packaging, smell, and taste with supplements. Fasting blood samples were collected at baseline and end of intervention to measure different outcomes. Multiple linear regression models were used to assess treatment effects on outcomes adjusting for confounding variables., Results: Patients taking ω-3 fatty acid plus vitamin D supplements showed a significant improvement in EDSS (β -0.18; 95% CI: -0.33, -0.04; P = 0.01), compared with placebo. Serum high-sensitivity C-reactive protein (β -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (β -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group. In addition, ω-3 fatty acid and vitamin D cosupplementation resulted in a significant reduction in serum insulin, insulin resistance, and total/HDL-cholesterol, and a significant increase in insulin sensitivity and serum HDL-cholesterol concentrations., Conclusion: Overall, taking ω-3 fatty acid and vitamin D supplements for 12 wk by patients with MS had beneficial effects on EDSS and metabolic status. This trial was registered at the Iranian website (www.irct.ir) for registration of clinical trials as IRCT2017090133941N20.

Objective: This study was designed to evaluate the effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes among subjects with gestational diabetes (GDM)., Methods: This randomized, double-blind, placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly allocated to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum (2 × 10 9 CFU/g each) (n = 30) or placebo (n = 30) for six weeks., Results: Compared with the placebo, probiotic supplementation resulted in significant decreases in fasting plasma glucose (FPG) (-5.3 ± 6.7 vs. +0.03 ± 9.0 mg/dL, p = .01), serum high-sensitivity C-reactive protein (hs-CRP) (-2.2 ± 2.7 vs. +0.5 ± 2.4 μg/mL, p < .001), plasma malondialdehyde (MDA) concentrations (-0.1 ± 0.8 vs. +0.5 ± 1.5 μmol/L, p = .03) and MDA/TAC ratio (-0.0003 ± 0.0008 vs. +0.0009 ± 0.002, p = .004), and a significant increase in total antioxidant capacity (TAC) levels (+65.4 ± 103.3 vs. -37.2 ± 143.7 mmol/L, p = .002). Probiotic supplementation did not affect pregnancy outcomes., Conclusions: Overall, probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG, serum hs-CRP, plasma TAC, MDA and oxidative stress index, but did not affect pregnancy outcomes.

Background: To our knowledge, no reports are available indicating the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome (PCOS). This research was done to assess the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with PCOS., Methods: This randomized double-blind, placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to take either synbiotic (n = 30) or placebo (n = 30) for 12 weeks. Endocrine, inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention., Results: After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (changes from baseline in synbiotic group: + 19.8 ± 47.3 vs. in placebo group: + 0.5 ± 5.4 nmol/L, p = 0.01), plasma nitric oxide (NO) (changes from baseline in synbiotic group: + 5.5 ± 4.8 vs. in placebo group: + 0.3 ± 9.1 μmol/L, p = 0.006), and decreased modified Ferriman Gallwey (mF-G) scores (changes from baseline in synbiotic group: - 1.3 ± 2.5 vs. in placebo group: - 0.1 ± 0.5, p = 0.01) and serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline in synbiotic group: - 950.0 ± 2246.6 vs. in placebo group: + 335.3 ± 2466.9 ng/mL, p = 0.02). We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress., Conclusions: Overall, synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG, mFG scores, hs-CRP and NO levels, but did not affect other hormonal status and biomarkers of oxidative stress., Trial Registration: This study was retrospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT201509115623N53 ), on 2015-09-27.

This study was carried out to assess the effects of Se supplementation on biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy (DN). This randomised, double-blind, placebo-controlled clinical trial was conducted among sixty patients with DN. Patients were randomly divided into two groups to take either 200 µg/d Se supplements as Se yeast (n 30) or placebo (n 30) for 12 weeks. In unadjusted analyses, compared with the placebo, Se supplementation led to a significant reduction in high-sensitivity C-reactive protein (hs-CRP) (-1069·2 (sd 1752·2) v. -135·3 (sd 1258·9) ng/ml, P=0·02), matrix metalloproteinase-2 (MMP-2) (-612·3 (sd 679·6) v. +76·0 (sd 309·1) ng/ml, P<0·001) and plasma malondialdehyde (MDA) concentrations (-0·1 (sd 0·7) v. +0·4 (sd 0·9) µmol/l, P=0·01). In addition, a significant increase in plasma total antioxidant capacity (TAC) (+174·9 (sd 203·9) v. +15·8 (sd 382·2) mmol/l, P=0·04) was observed following supplementation with Se compared with the placebo. Subjects who received Se supplements experienced a borderline statistically significant decrease in serum protein carbonyl (PCO) levels (P=0·06) compared with the placebo. When we adjusted the analysis for baseline values of biochemical parameters, age and BMI, serum hs-CRP (P=0·14) and MDA levels (P=0·16) became non-significant, whereas plasma nitric oxide (NO) (P=0·04) and glutathione (GSH) (P<0·001) became statistically significant, and other findings did not change. Supplementation with Se had no significant effect on NO, transforming growth factor β (TGF-β), advanced glycation end products (AGE), PCO and GSH compared with the placebo. Overall, our study demonstrated that Se supplementation among DN patients had favourable effects on serum MMP-2, plasma NO, TAC and GSH, but did not affect hs-CRP, TGF-β, AGE, PCO and MDA.

Unlabelled: Limited data are available indicating the effects of chromium administration on endocrine profiles, biomarkers of inflammation, and oxidative stress among women with polycystic ovary syndrome (PCOS). This study was done to assess the effects of chromium administration on endocrine profiles, biomarkers of inflammation, and oxidative stress in women with PCOS. Participants of this randomized, double-blind, placebo-controlled trial consisted of 60 patients with PCOS who received either 200 μg chromium supplements (n = 30) or placebo daily (n = 30) for 8 weeks. Endocrine profiles, inflammatory factors, and biomarkers of oxidative stress were assessed at study baseline and at the end of intervention. After 8 weeks of intervention, pregnancy rate in chromium group was higher than that in the placebo group: 16.7 % (5/30) vs. 3.3 % (1/30), P = 0.08. In addition, prevalence of acne (20.0 vs. 3.3 %, P = 0.04) decreased following the administration of chromium supplements compared with the placebo. Taking chromium led to a significant reduction in hirsutism (-1.8 ± 2.5 vs. -0.2 ± 0.8, P = 0.002), serum high-sensitivity C-reactive protein (hs-CRP) (-717.0 ± 1496.1 vs. +227.1 ± 1669.6 ng/mL, P = 0.02), plasma malondialdehyde (MDA) (-0.1 ± 0.7 vs. +1.1 ± 1.5 μmol/L, P < 0.001), and a significant increase in plasma total antioxidant capacity (TAC) concentrations (+250.7 ± 265.2 vs. +13.0 ± 201.6 mmol/L, P < 0.001). We failed to find any significant effect of chromium administration on endocrine profiles and nitric oxide (NO) and glutathione (GSH) levels. Overall, taking chromium for 8 weeks among women with PCOS had beneficial effects on acne, hirsutism, hs-CRP, TAC, and MDA levels, but it did not affect endocrine profiles, NO, and GSH., Clinical Trial Registration Number: IRCT201506105623N44 ( www.irct.ir ).

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]

The current research was performed to evaluate the effects of omega-3 fatty acids and vitamin E co-supplementation on clinical signs and metabolic status in people with Parkinson's disease (PD). This randomized double-blind placebo-controlled clinical trial was conducted in 60 patients with PD. Participants were randomly assigned into two groups to receive either 1000 mg omega-3 fatty acids from flaxseed oil plus 400 IU vitamin E supplements (n = 30) or placebo (n = 30) for 12 weeks. Unified Parkinson's disease rating stage (UPDRS) were recorded at baseline and the after 3-month intervention. After 12 weeks' intervention, compared with the placebo, omega-3 fatty acids and vitamin E co-supplementation led to a significant improve in UPDRS (−3.3 ± 10.0 vs. +4.4 ± 14.9, P = 0.02). Furthermore, co-supplementation decreased high-sensitivity C-reactive protein (hs-CRP) (−0.3 ± 0.6 vs. +0.3 ± 0.3 μg/mL, P < 0.001), and increased total antioxidant capacity (TAC) (+65.2 ± 68.7 vs. +16 ± 52.4 μmol/L, P = 0.003) and glutathione (GSH) concentrations (+41.4 ± 80.6 vs. −19.6 ± 55.9 μmol/L, P = 0.001) compared with the placebo. Additionally, co-supplementation meaningfully decreased insulin (−2.1 ± 4.9 vs. +1.4 ± 6.2 μIU/mL, P = 0.01), homeostasis model of assessment-estimated insulin resistance (−0.7 ± 1.8 vs.+0.3 ± 1.6, P = 0.02) and Beta cell function (−5.9 ± 13.9 vs. +5.7 ± 25.5, P = 0.03), and increased quantitative insulin sensitivity check index (+0.009 ± 0.02 vs. −0.006 ± 0.03, P = 0.03) compared with the placebo. Overall, our study demonstrated that omega-3 fatty acids and vitamin E co-supplementation in people with PD had favorable effects on UPDRS, hs-CRP, TAC, GSH and markers of insulin metabolism. [ABSTRACT FROM AUTHOR]

Objective To our knowledge, data on comparison of myo-inositol and metformin on clinical, metabolic and genetic parameters in subjects with polycystic ovary syndrome ( PCOS) are limited. This study was carried out to compare myo-inositol and metformin on clinical, metabolic and genetic parameters in subjects with PCOS. Design, patients and measurements: This randomized controlled trial was conducted among 60 subjects with PCOS aged 18-40 years. Subjects were randomly allocated into two groups to receive either myo-inositol (N=30) or metformin (N=30) for 12 weeks. Gene expression of inflammatory cytokines was assessed in peripheral blood mononuclear cells ( PBMCs) of PCOS women by RT- PCR. Results After the 12-week intervention, compared with metformin, myo-inositol intake significantly decreased serum total testosterone (−1.4±4.2 vs +0.7±1.4 nmol/L, P=.03), modified Ferriman-Gallwey ( mF-G) scores (−1.1±0.7 vs −0.5±0.8, P=.01) and serum high-sensitivity C-reactive protein (hs- CRP) levels (−2.6±3.9 vs +0.2±1.5 mg/L, P<.001). RT- PCR demonstrated that compared with metformin, myo-inositol downregulated gene expression of interleukin-1 ( IL-1) ( P=.02) in PBMCs of subjects with PCOS. We did not observe any significant effect of myo-inositol intake compared with metformin on other hormonal profiles, plasma nitric oxide ( NO) or gene expression of IL-8 and tumour necrosis factor alpha ( TNF-α). Conclusions Overall, taking myo-inositol, compared with metformin, for 12 weeks in patients with PCOS with hyperinsulinism and normoinsulinism had beneficial effects on total testosterone, mFG scores, serum hs- CRP levels and gene expression of IL-1, but did not affect other hormonal profiles, NO levels or gene expression of IL-8 and TNF-α. [ABSTRACT FROM AUTHOR]

Background: Vitamin D might be beneficial in diabetic patients with coronary artery disease (CAD) through its favorable effects on metabolic profiles and biomarkers of inflammation and oxidative stress.Objective: This study was performed to examine the effects of 6 mo of vitamin D supplementation on metabolic status in diabetic patients with CAD.Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted in 60 vitamin D-deficient diabetic patients with CAD aged 40-85 y. Subjects were randomly assigned into 2 groups to take either 50,000-IU vitamin D supplements (n = 30) or placebo (n = 30) every 2 wk for 6 mo. Fasting blood samples were obtained at the beginning of the study and after the 6-mo intervention to quantify glycemic indicators, lipid concentrations, and biomarkers of inflammation and oxidative stress.Results: Compared with placebo, vitamin D supplementation resulted in significant reductions in fasting plasma glucose (-14.9 ± 7.1 compared with +19.3 ± 7.1 mg/dL; P = 0.001), serum insulin (-2.7 ± 1.1 compared with +1.8 ± 1.1 μIU/mL; P = 0.006), homeostasis model assessment of insulin resistance (-0.7 ± 0.3 compared with +0.5 ± 0.3; P = 0.01), and β cell function (-9.1 ± 4.2 compared with +5.7 ± 4.2; P = 0.01) and a significant increase in serum vitamin D (+6.8 ± 0.9 compared with +0.1 ± 0.9 ng/mL; P < 0.001) and the Quantitative Insulin Sensitivity Check Index (+0.008 ± 0.004 compared with -0.007 ± 0.004; P = 0.01). In addition, changes in serum high-sensitivity C-reactive protein (hs-CRP; -1.0 ± 0.5 compared with +0.6 ± 0.5 μg/mL; P = 0.02), plasma nitric oxide (NO; +7.0 ± 2.0 compared with -4.6 ± 2.0 μmol/L; P < 0.001), total reduced glutathione (GSH; +104 ± 16.4 compared with +24.8 ± 16.4 μmol/L; P = 0.001), and malondialdehyde concentrations (-0.2 ± 0.1 compared with +0.2 ± 0.1 μmol/L; P < 0.001) in the supplemented group were significantly different from the changes in these indicators in the placebo group.Conclusions: Overall, 6 mo of vitamin D supplementation among vitamin D-deficient diabetic patients with CAD had beneficial effects on glycemic control and serum hs-CRP, NO, GSH, and malondialdehyde concentrations. This trial was registered on the Iranian website (www.irct.ir) for registration of clinical trials as IRCT201510315623N56. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study was conducted to establish the comparative effects of carbohydrate versus fat restriction on metabolic indices in Type 2 diabetic (T2D) patients with coronary heart disease (CHD). METHODS: This randomized, clinical trial was done among 56 overweight persons with T2D and CHD aged 40-85 years old. The patients were randomly allocated to take either a highcarbohydrate (HC) diet (60-65% carbohydrates and 20-25% fats) (n = 28) or a restricted carbohydrate (RC) diet (43-49% carbohydrate and 36-40% fats) (n = 28) for 8 weeks to determine metabolic status. RESULTS: After 8 weeks of treatment, RC diet decreased fasting plasma glucose (FPG) (-11.5 ± 28.3 vs. +7.0 ± 26.9 mg/dl, P = 0.010) and high-sensitivity C-reactive protein (hs-CRP) (-564.3 ± 1280.1 vs. +286.1 ± 1789.2 ng/ml, P = 0.040) compared with a HC diet. Moreover, compared with a HC diet, RC diet increased total antioxidant capacity (TAC) (+274.8 ± 111.5 vs. +20.2 ± 82.5 mmol/l, P < 0.001) and glutathione (GSH) levels (+51.6 ± 111.5 vs. -32.6 ± 88.5 µmol/l, P = 0.003). No significant alterations between the two groups were found in terms of their effect on other metabolic profiles. CONCLUSION: RC diet in overweight T2D with CHD had beneficial effects on FPG, hs-CRP, TAC, and GSH values. [ABSTRACT FROM AUTHOR]

Background & Aims This study was designed to determine the effects of the Dietary Approaches to Stop Hypertension ( DASH) diet on weight loss and metabolic status in overweight patients with non-alcoholic fatty liver disease ( NAFLD). Methods This randomized controlled clinical trial was done among 60 overweight and obese patients with NAFLD. Patients were randomly allocated to consume either the control ( n = 30) or the DASH eating pattern ( n = 30) for 8 weeks. Both diets were designed to be calorie-restricted. Both diets were consisted of 52-55% carbohydrates, 16-18% proteins and 30% total fats; however, the DASH diet was designed to be rich in fruits, vegetables, whole grains, and low-fat dairy products and low in saturated fats, cholesterol and refined grains. Results Adherence to the DASH eating pattern, compared to the control diet, weight ( P = 0.006), BMI ( P = 0.01), alanine aminotransferase ( ALT) ( P = 0.02), alkalin phosphatase ( ALP) ( P = 0.001), insulin levels ( P = 0.01), homoeostasis model of assessment-estimated insulin resistance ( HOMA- IR) ( P = 0.01) significantly decreased and quantitative insulin sensitivity check index ( QUICKI) ( P = 0.004) significantly increased. Compared with the control diet, the DASH diet has resulted in significant reductions in serum triglycerides ( P = 0.04) and total-/ HDL-cholesterol ratio ( P = 0.01). Finally, decreased concentrations of serum high-sensitivity C-reactive protein (hs- CRP) ( P = 0.03), malondialdehyde ( MDA) ( P = 0.04), increased levels of nitric oxide ( NO) ( P = 0.01) and glutathione ( GSH) ( P = 0.009) were found in the DASH group compared with the control group. Conclusions Consumption of DASH diet for 8 weeks among patients with NAFLD had beneficial effects on weight, BMI, ALT, ALP, triglycerides, markers of insulin metabolism, inflammatory markers, GSH and MDA. [ABSTRACT FROM AUTHOR]

The article presents the discussion on expression of concern for the effects of selenium supplementation on biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy: a randomised, double-blind, placebo-controlled trial.

Objective: The aim of this study was to determine the effect of vitamin D and probiotic co-administration on mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome (PCOS). Methods: This randomized, double-blinded, placebo-controlled clinical trial was carried out on 60 subjects, aged 18–40 years old. Subjects were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/day probiotic (n = 30) or placebo (n = 30) for 12 weeks. Results: Vitamin D and probiotic co-supplementation, compared with the placebo, significantly improved beck depression inventory [β (difference in the mean of outcomes measures between treatment groups) − 0.58; 95% CI, − 1.15, − 0.02; P = 0.04], general health questionnaire scores (β − 0.93; 95% CI, − 1.78, − 0.08; P = 0.03) and depression, anxiety and stress scale scores (β − 0.90; 95% CI, − 1.67, − 0.13; P = 0.02). Vitamin D and probiotic co-supplementation was associated with a significant reduction in total testosterone (β − 0.19 ng/mL; 95% CI, − 0.28, − 0.10; P < 0.001), hirsutism (β − 0.95; 95% CI, − 1.39, − 0.51; P < 0.001), high-sensitivity C-reactive protein (hs-CRP) (β − 0.67 mg/L; 95% CI, − 0.97, − 0.38; P < 0.001) and malondialdehyde (MDA) levels (β − 0.25 μmol/L; 95% CI, − 0.40, − 0.10; P = 0.001), and a significant increase in total antioxidant capacity (TAC) (β 82.81 mmol/L; 95% CI, 42.86, 122.75; P < 0.001) and total glutathione (GSH) levels (β 40.42 μmol/L; 95% CI, 4.69, 76.19; P = 0.02), compared with the placebo. Conclusions: Overall, the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels. Trial Registration: This study was retrospectively registered in the Iranian website (www.irct.ir) for registration of clinical trials (IRCT20170513033941N37). [ABSTRACT FROM AUTHOR]

Background: This study was conducted to assess the effects of folate supplementation on carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress in carbamazepine-treated epileptic children. Methods: This randomized, double-blind, placebo-controlled trial was carried out in 54 epileptic children aged 2–12 years old receiving carbamazepine monotherapy. Participants were randomly allocated into two groups to receive either 5 mg folate supplements or placebo (n = 27 in each group) for 12 weeks. Results: After the 12-week intervention, compared with the placebo, folate supplementation resulted in a significant reduction in plasma homocysteine (Hcy) (changes from baseline − 2.1 ± 2.5 vs. +0.1 ± 0.4 μmol/L, P < 0.001), serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline − 1.5 ± 3.5 vs. +0.4 ± 1.4 mg/L, P = 0.01), a significant increase in plasma nitric oxide (NO) (changes from baseline + 1.9 ± 5.8 vs. −2.0 ± 6.4 μmol/L, P = 0.02), and total antioxidant capacity (TAC) concentrations (changes from baseline + 88.6 ± 116.0 vs. +1.8 ± 77.4 mmol/L, P = 0.002). We did not observe any significant effects in mean levels of left and right CIMT, maximum levels of left and right CIMT, and total glutathione (GSH) and malondialdehyde (MDA) levels following the supplementation of folate compared with the placebo. Conclusions: Overall, folate supplementation at a dosage of 5 mg/day for 12 weeks among epileptic children receiving carbamazepine had beneficial effects on Hcy, hs-CRP, NO, and TAC levels, but did not affect CIMT, and GSH and MDA levels. [ABSTRACT FROM AUTHOR]

Background This study was carried out to evaluate the effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in diabetic people with coronary heart disease (CHD). Methods This randomized, double-blind, placebo-controlled trial was carried out among 60 diabetic people with CHD, aged 45–85 years old. Subjects were randomly allocated into two groups to receive either 50,000 IU vitamin D every 2 weeks plus 8 × 10 9  CFU/g probiotic of Lactocare Zisttakhmir Co (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were obtained at baseline and after the 12-week intervention to determine metabolic profiles. Results After the 12-week intervention, compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant improvements in beck depression inventory total score (−2.8 ± 3.8 vs. −0.9 ± 2.1, P = 0.01), beck anxiety inventory scores (−2.1 ± 2.3 vs. −0.8 ± 1.4, P = 0.009) and general health questionnaire scores (−3.9 ± 4.1 vs. −1.1 ± 3.4, P = 0.005). Compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant reductions in serum insulin levels (−2.8 ± 3.8 vs. +0.2 ± 4.9 μIU/mL, P = 0.009), homeostasis model of assessment-estimated insulin resistance (−1.0 ± 1.6 vs. −0.1 ± 1.5, P = 0.02), and a significant increase in serum 25-OH-vitamin D (+11.8 ± 5.9 vs. +0.1 ± 1.4 ng/mL, P < 0.001), the quantitative insulin sensitivity check index (+0.03 ± 0.04 vs. −0.001 ± 0.01, P = 0.003) and serum HDL-cholesterol levels (+2.3 ± 3.5 vs. −0.5 ± 3.8 mg/dL, P = 0.004). In addition, changes in serum high sensitivity C-reactive protein (hs-CRP) (−950.0 ± 1811.2 vs. +260.5 ± 2298.2 ng/mL, P = 0.02), plasma nitric oxide (NO) (+1.7 ± 4.0 vs. −1.4 ± 6.7 μmol/L, P = 0.03) and plasma total antioxidant capacity (TAC) (+12.6 ± 41.6 vs. −116.9 ± 324.2 mmol/L, P = 0.03) in the supplemented group were significantly different from the changes in these indicators in the placebo group. Conclusions Overall, vitamin D and probiotic co-supplementation after 12 weeks among diabetic people with CHD had beneficial effects on mental health parameters, serum hs-CRP, plasma NO, TAC, glycemic control and HDL-cholesterol levels. Clinical trial registration number http://www.irct.ir : IRCT2017073033941N4. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to evaluate the effects of mulberry extract administration on markers of insulin metabolism, lipid concentrations, and biomarkers of inflammation and oxidative stress in patients with diabetic nephropathy (DN).Materials and Methods: Sixty patients were randomly allocated into 2 groups to receive either 300 mg/d of mulberry extract (n = 30) or placebo (n = 30), twice per day for 12 weeks. Fasting blood samples were taken at the onset of the study and 12 weeks after supplementation to examine markers of insulin metabolism, lipid concentrations, and biomarkers of inflammation and oxidative stress.Results: Mulberry extract, compared to placebo, resulted in significant reductions in serum triglycerides (-37.3 ± 64.7 mg/dL versus 3.0 ± 78.8 mg/dL, P = .03) and very low-density lipoprotein cholesterol (-7.4 ± 12.9 mg/dL versus 0.6 ± 15.8 mg/dL, P = .03), and a significant increase in high-density lipoprotein cholesterol concentration (0.5 ± 4.0 mg/dL versus -2.0 ± 5.0 mg/dL, P = .03). Other significant changes were in serum high-sensitivity C-reaction protein (-2.3 ± 4.5 µg/mL versus -0.1 ± 2.2 µg/mL, P = .02), plasma glutathione (87.8 ± 159.7 µmol/L versus -24.2 ± 138.8 µmol/L, P = .005) and malondialdehyde (-0.03 ± 0.5 µmol/L versus 0.7 ± 1.0 µmol/L, P < .001).   Conclusions. These findings showed that mulberry extract administration had favorable effects on serum lipids, HSCRP, glutathione, and malondialdehyde levels in DN patients; however, it did not affect markers of insulin metabolism or biomarkers of inflammation and oxidative stress. [ABSTRACT FROM AUTHOR]

Background: To the best of our knowledge, data on effects of probiotic administration on hormonal profiles, biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome (PCOS) are scarce. This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles, biomarkers of inflammation and oxidative stress in women with PCOS. Methods: This randomized, double-blind, placebo-controlled trial was conducted on 60 women with PCOS, aged 18-40 years old. Subjects were randomly assigned into 2 groups to receive either probiotics or placebo (n = 30 each group) for 12 weeks. Metabolic profiles were quantified at baseline and after a 12-week intervention. Results: After the 12-week intervention, compared with placebo, probiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (+25.9 ± 32.5 vs. +0.5 ± 15.6 nmol/L, P < 0.001) and plasma total antioxidant capacity (TAC) (+8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L, P = 0.04), and significantly decreased serum total testosterone (-0.2 ± 0.7 vs. +0.2 ± 0.6 ng/mL, P = 0.03), modified Ferriman-Gallwey (mF-G) scores (-1.7 ± 1.5 vs. -0.2 ± 1.0, P < 0.001), serum high-sensitivity C-reactive protein (hs-CRP) (-1150.0 ± 1295.2 vs. +202.5 ± 1426.3 ng/mL, P < 0.001) and plasma malondialdehyde (MDA) concentrations (-0.2 ± 0.6 vs. +0.9 ± 1.3 µmol/L, P < 0.001). We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles. Conclusion: Overall, probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone, SHBG, mFG scores, hs-CRP, TAC and MDA levels but did not affect other metabolic profiles. [ABSTRACT FROM AUTHOR]

Objective This study was conducted to evaluate the effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). Methods This randomized, double-blind, placebo-controlled trial was performed among 60 patients with grade 3 DFU according to "Wagner–Meggitt’s" criteria. Participants were randomly divided into two groups (each 30 participants) and received either 50,000 IU vitamin D supplements every 2 weeks for 12 weeks (group A) or placebo (group B). Fasting blood samples were taken at study baseline and after 12-week intervention to determine related markers. Results After 12 weeks of intervention, compared with the placebo, vitamin D supplementation resulted in a significant reduction in ulcer length (− 2.1 ± 1.1 vs. − 1.1 ± 1.1 cm, P = 0.001), width (− 2.0 ± 1.2 vs. − 1.1 ± 1.0 cm, P = 0.02) and depth (− 1.0 ± 0.5 vs. − 0.5 ± 0.5 cm, P < 0.001), and erythema rate (100% vs. 80%, P = 0.01). In addition, in supplemented patients changes in serum insulin concentration (− 3.4 ± 9.2 vs. + 2.8 ± 9.3 μIU/mL, P = 0.01), homeostasis model of assessment-estimated insulin resistance (− 1.5 ± 4.1 vs. + 1.7 ± 5.1, P = 0.01), the quantitative insulin sensitivity check index (+ 0.006 ± 0.02 vs. − 0.006 ± 0.02, P = 0.03) and HbA1c (− 0.6 ± 0.6 vs. − 0.1 ± 0.5%, P = 0.004) were significantly different from those of patients in the placebo group. Additionally, following supplementation with vitamin D, significant reductions in serum total- (− 15.8 ± 18.9 vs. + 5.3 ± 31.8 mg/dL, P = 0.003), LDL- (− 17.2 ± 19.8 vs. + 2.2 ± 28.6 mg/dL, P = 0.003), total-/HDL-cholesterol ratio (− 1.1 ± 0.8 vs. − 0.2 ± 1.1, P = 0.001), high sensitivity C-reactive protein (hs-CRP) (− 0.4 ± 2.5 vs. + 1.9 ± 4.2 μg/mL, P = 0.01), erythrocyte sedimentation rate (ESR) (− 34.7 ± 32.4 vs. − 18.0 ± 26.6 mm/h, P = 0.03) and plasma malondialdehyde (MDA) concentrations (− 0.7 ± 0.9 vs. − 0.2 ± 0.5 μmol/L, P = 0.008) were seen compared with the placebo. Conclusions Overall, vitamin D supplementation for 12 weeks among patients with DFU had beneficial effects on glucose homeostasis, total-, LDL-, total-/HDL-cholesterol, ESR, hs-CRP and MDA levels. In addition, vitamin D may have played an indirect role in wound healing due to its effect on improved glycemic control. [ABSTRACT FROM AUTHOR]