Effects of omega-3 fatty acid plus alpha-tocopherol supplementation on malnutrition-inflammation score, biomarkers of inflammation and oxidative stress in chronic hemodialysis patients.

OBJECTIVE: The current study was carried out to assess the effects of omega-3 fatty acid and alpha-tocopherol co-supplementation on malnutrition-inflammation score (MIS), biomarkers of inflammation and oxidative stress in chronic hemodialysis (HD) patients. METHODS: In a randomized double-blind placebo-controlled clinical trial, 120 patients with chronic HD were included. Patients were randomly allocated into four groups to receive: (1) 1250 mg/day omega-3 fatty acid containing 600 mg EPA and 300 mg DHA + alpha-tocopherol placebo (n = 30); (2) 400 IU/day alpha-tocopherol + omega-3 fatty acids placebo (n = 30); (3) 1250 mg omega-3 fatty acids/day + 400 IU/day alpha-tocopherol (n = 30); and (4) omega-3 fatty acids placebo + alpha-tocopherol placebo (n = 30) for 12 weeks. RESULTS: After 12 weeks of intervention, all three groups of alpha-tocopherol only, individual omega-3 fatty acids, and combined omega-3 fatty acids and alpha-tocopherol experienced a significant improvements in MIS compared with the placebo group; however, improvements were much greater in the individual omega-3 fats (-1.4 ± 1.4) and combined omega-3 fats and alpha-tocopherol (-1.1 ± 2.3) groups compared with alpha-tocopherol group alone (-0.5 ± 1.7, P = 0.004). Furthermore, both individual and combined intervention with omega-3 fats and alpha-tocopherol led to a significant increase in plasma nitric oxide (NO) (combined group: +17.6 ± 29.3; alpha-tocopherol: +43.1 ± 36.3; omega-3 fats: +31.0 ± 40.0; and placebo: -0.5 ± 18.5 µmol/L, respectively, P < 0.001) and total antioxidant capacity (TAC) (+64.9 ± 113.6, +53.0 ± 144.6, +57.6 ± 157.8 and -69.9 ± 215.1 mmol/L, respectively, P = 0.004) levels. CONCLUSION: Overall, omega-3 fatty acids and alpha-tocopherol co-supplementation for 12 weeks among HD patients improved MIS, plasma NO and TAC levels. Future studies with longer duration of the intervention are needed to confirm the validity of our findings. CLINICAL REGISTRATION: www.irct.ir as IRCT201410245623N28.

Effect of the omega-3 fatty acid plus vitamin E supplementation on subjective global assessment score, glucose metabolism, and lipid concentrations in chronic hemodialysis patients.

SCOPE: This study was conducted to determine the effects of omega-3 fatty acid plus vitamin E supplementation on subjective global assessment (SGA) score and metabolic profiles in chronic hemodialysis (HD) patients. METHODS AND RESULTS: This randomized double-blind placebo-controlled clinical trial was conducted among 120 chronic HD patients. Participants were randomly divided into four groups to receive: (i) 1250 mg/day omega-3 fatty acid containing 600 mg eicosapentaenoic acid and 300 mg docosahexaenoic acid + vitamin E placebo (n = 30), (ii) 400 IU/day vitamin E + omega-3 fatty acids placebo (n = 30), (iii) 1250 mg omega-3 fatty acids/day + 400 IU/day vitamin E (n = 30), and (iv) omega-3 fatty acids placebo + vitamin E placebo (n = 30) for 12 wk. Fasting blood samples were taken at baseline and after 12-wk intervention to measure metabolic profiles. Patients who received combined omega-3 fatty acids and vitamin E supplements compared with vitamin E, omega-3 fatty acids, and placebo had significantly decreased SGA score (p < 0.001), fasting plasma glucose (p = 0.01), serum insulin levels (p = 0.001), homeostasis model of assessment insulin resistance (p = 0.002), and improved quantitative insulin sensitivity check index (p = 0.006). CONCLUSION: Omega-3 fatty acids plus vitamin E supplementation for 12 wk among HD patients had beneficial effects on SGA score and metabolic profiles.

The effects of folate supplementation on inflammatory factors and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: This study was conducted to determine the effects of folate supplementation on inflammatory factors and biomarkers of oxidative stress among women with polycystic ovary syndrome (PCOS). DESIGN, PATIENTS AND MEASUREMENTS: This randomized, double-blind, placebo-controlled clinical trial was conducted among 69 women diagnosed with PCOS and aged 18-40 year old. Participants were randomly assigned to three groups receiving the following: (1) folate-1: 1 mg/d folate supplements (N = 23); (2) folate-5: 5 mg/d folate supplements (N = 23) and (3) placebo (N = 23) for 8 weeks. Fasting blood samples were taken at the beginning of the study and after 8 weeks to measure homocysteine (Hcy), inflammatory factors including high-sensitivity C-reactive protein (hs-CRP), nitric oxide (NO), biomarkers of oxidative stress including total antioxidant capacity (TAC), glutathione (GSH), malondialdehyde (MDA) and homoeostatic model assessment-beta cell function (HOMA-B). RESULTS: Supplementation with 5 mg/d folate resulted in reduced plasma Hcy (-2·23 vs -1·86 and 1·16 µm, respectively, P < 0·05), HOMA-B (-7·63 vs 1·43 and 13·66, respectively, P < 0·05), serum hs-CRP (-212·2 vs -262·4 and 729·8 µg/l, respectively, P < 0·05) and plasma MDA concentrations (-0·48 vs -0·24 and 0·69 µm, respectively, P < 0·01) compared with folate-1 and placebo groups. Furthermore, a significant rise in plasma TAC (0·64 vs -3·53 and -215·47 mm, respectively, P < 0·01) and GSH levels (162·1 vs 195·8 and -158·2 µm, respectively, P < 0·01) was also observed following the administration of 5 mg/d folate supplements compared with folate-1 and placebo groups. CONCLUSIONS: In conclusion, folate supplementation (5 mg/d) in women with PCOS had beneficial effects on inflammatory factors and biomarkers of oxidative stress.

Effects of synbiotic food consumption on metabolic status of diabetic patients: a double-blind randomized cross-over controlled clinical trial.

BACKGROUND & AIMS: We are aware of no study indicating the effects of synbiotic food consumption on metabolic profiles, inflammation and oxidative stress among diabetic patients. The aim of the current study was to investigate the effects of synbiotic food consumption on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic patients. METHODS: This randomized double-blinded cross-over controlled clinical trial was performed among 62 diabetic patients aged 35-70 y. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n = 62) or control food (n = 62) for 6 weeks. A 3-week washout period was applied following which subjects were crossed over to the alternate treatment arm for an additional 6 weeks. The synbiotic food consisted of a probiotic viable and heat-resistant Lactobacillus sporogenes (1 × 10(7) CFU), 0.04 g inulin (HPX) as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and prebiotic inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods three times a day. Fasting blood samples were taken at baseline and after a 6-wk intervention to measure metabolic profiles, hs-CRP and biomarkers of oxidative stress. RESULTS: Consumption of a synbiotic food, compared to the control, resulted in a significant decrease in serum insulin levels (changes from baseline: -1.75 ± 0.60 vs. +0.95 ± 1.09 µIU/mL, P = 0.03). Although we failed to find a significant effect of synbiotic food consumption on total- and LDL-cholesterol levels and HOMA-IR, the effects on FPG (22.3 vs. 4.2 mg/dL, P = 0.09), serum triglycerides (45.9 vs. 20.6 mg/dL, P = 0.08) and HDL-cholesterol levels (3.1 vs. -2 mg/dL, P = 0.06) tended to be significant. A significant reduction in serum hs-CRP levels (-1057.86 ± 283.74 vs. 95.40 ± 385.38 ng/mL, P = 0.01) was found following the consumption of synbiotic food compared with the control group. Supplementation with the synbiotic food led to a significant increase in plasma total GSH (319.98 vs. 19.73 µmol/L, P < 0.001) and serum uric acid levels (+0.7 vs. -0.1 mg/dL, P = 0.04) compared to the control food. No significant effect of the synbiotic food was observed on plasma TAC levels. CONCLUSIONS: In conclusion, consumption of a synbiotic food for 6 weeks among diabetic patients had significant effects on serum insulin, hs-CRP, uric acid and plasma total GSH levels. CLINICAL TRIAL REGISTRATION NUMBER: www.irct.ir: IRCT201201195623N1.

Effect of multispecies probiotic supplements on metabolic profiles, hs-CRP, and oxidative stress in patients with type 2 diabetes.

BACKGROUND: We are aware of no study that has indicated the effects of daily consumption of multispecies probiotic supplements on metabolic profiles, high-sensitivity C-reactive protein (hs-CRP), and oxidative stress in diabetic patients. OBJECTIVE: This study was designed to determine the effects of multispecies probiotic supplements on metabolic profiles, hs-CRP, and oxidative stress in diabetic patients. METHODS: This randomized double-blind placebo-controlled clinical trial was performed on 54 diabetic patients aged 35-70 years. Subjects were randomly assigned to take either a multispecies probiotic supplement (n = 27) or placebo (n = 27) for 8 weeks. The multispecies probiotic supplement consisted of 7 viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) CFU), L. casei (7 × 10(9) CFU), L. rhamnosus (1.5 × 10(9) CFU), L. bulgaricus (2 × 10(8) CFU), Bifidobacterium breve (2 × 10(10) CFU), B. longum (7 × 10(9) CFU), Streptococcus thermophilus (1.5 × 10(9) CFU), and 100 mg fructo-oligosaccharide. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles, hs-CRP, and biomarkers of oxidative stress including plasma total antioxidant capacity and total glutathione (GSH). RESULTS: Between-group comparisons of fasting plasma glucose (FPG) revealed that consumption of probiotic supplements prevented a rise in FPG (+28.8 ± 8.5 for placebo vs. +1.6 ± 6 mg/dl for probiotic group, p = 0.01). Although a significant within-group increase in serum insulin and low-density lipoprotein cholesterol levels was found in both the probiotic group and the placebo group, the changes were similar between the two groups. We observed a significant increase in HOMA-IR (homeostasis model of assessment-insulin resistance) in both the probiotic group (p = 0.02) and the placebo group (p = 0.001); however, the increase in the placebo group was significantly higher than that in the probiotic group (+2.38 vs. +0.78, p = 0.03). Mean changes in serum hs-CRP were significantly different between the two groups (-777.57 for the probiotic group vs. +878.72 ng/ml for the placebo group, p = 0.02). Probiotic supplementation led to a significant increase in plasma GSH levels compared to placebo (240.63 vs. -33.46 µmol/l, p = 0.03). CONCLUSION: In conclusion, multispecies probiotic supplementation, compared with placebo, for 8 weeks in diabetic patients prevented a rise in FPG and resulted in a decrease in serum hs-CRP and an increase in plasma total GSH.

Vitamin D supplementation affects serum high-sensitivity C-reactive protein, insulin resistance, and biomarkers of oxidative stress in pregnant women.

Unfavorable metabolic profiles and oxidative stress in pregnancy are associated with several complications. This study was conducted to determine the effects of vitamin D supplementation on serum concentrations of high-sensitivity C-reactive protein (hs-CRP), metabolic profiles, and biomarkers of oxidative stress in healthy pregnant women. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 pregnant women aged 18-40 y old at 25 wk of gestation. Participants were randomly assigned to receive either 400 IU/d cholecalciferol supplements (n = 24) or placebo (n = 24) for 9 wk. Fasting blood samples were taken at study baseline and after 9 wk of intervention to quantify serum concentrations of hs-CRP, lipid concentrations, insulin, and biomarkers of oxidative stress. After 9 wk of intervention, the increases in serum 25-hydroxyvitamin D and calcium concentrations were greater in the vitamin D group (+3.7 µg/L and +0.20 mg/dL, respectively) than in the placebo group (-1.2 µg/L and -0.12 mg/dL, respectively; P < 0.001 for both). Vitamin D supplementation resulted in a significant decrease in serum hs-CRP (vitamin D vs. placebo groups: -1.41 vs. +1.50 µg/mL; P-interaction = 0.01) and insulin concentrations (vitamin D vs. placebo groups: -1.0 vs. +2.6 µIU/mL; P-interaction = 0.04) and a significant increase in the Quantitative Insulin Sensitivity Check Index score (vitamin D vs. placebo groups: +0.02 vs. -0.02; P-interaction = 0.006), plasma total antioxidant capacity (vitamin D vs. placebo groups: +152 vs. -20 mmol/L; P-interaction = 0.002), and total glutathione concentrations (vitamin D vs. placebo groups: +205 vs. -32 µmol/L; P-interaction = 0.02) compared with placebo. Intake of vitamin D supplements led to a significant decrease in fasting plasma glucose (vitamin D vs. placebo groups: -0.65 vs. -0.12 mmol/L; P-interaction = 0.01), systolic blood pressure (vitamin D vs. placebo groups: -0.2 vs. +5.5 mm Hg; P-interaction = 0.01), and diastolic blood pressure (vitamin D vs. placebo groups: -0.4 vs. +3.1 mm Hg; P-interaction = 0.01) compared with placebo. In conclusion, vitamin D supplementation for 9 wk among pregnant women has beneficial effects on metabolic status.