Co-administration of probiotic and vitamin D significantly improves cognitive function in schizophrenic patients: A double-blinded randomized controlled trial.

AIM: Manipulation of the intestinal microbiome and supplying vitamin D can attenuate psychiatric symptoms in schizophrenic patients. The current study tried to evaluate the effects of probiotic/vitamin D supplementation on the cognitive function and disease severity of schizophrenic patients. METHODS: In the present study, 70 patients (aged 18-65) with schizophrenia were recruited. Participants were randomly allocated to the placebo (n = 35) and intervention (probiotic supplements+400 IU vitamin D, n = 35) groups. Severity of disease and cognitive function (primary outcomes) were evaluated by Positive and Negative Syndrome Scale (PANSS) and Montreal Cognitive Assessment (MoCA) tests, respectively. Moreover, lipid profile, body mass index (BMI), gastrointestinal (GI) problems, serum C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were evaluated as secondary outcomes. RESULTS: A total of 69 patients completed the study. The MoCA score was increased by 1.96 units in the probiotic-containing supplement group compared to the placebo (p = 0.004). Also, the percentage of subjects with MoCA score ≥ 26 rose significantly in the intervention group (p = 0.031). Moreover, TC (p = 0.011), FBS (p = 0.009), and CRP (p < 0.001) significantly decreased in the supplement group compared to the placebo. Although the probiotic supplement reduced PANSS score by 2.82 units, the difference between the study groups was not statistically significant (p = 0.247). CONCLUSION: Co-administration of probiotics and vitamin D has beneficial effects on the improvement of cognitive function in schizophrenic patients.

Effect of a Probiotic Supplement Containing Lactobacillus Acidophilus and Bifidobacterium Animalis Lactis on Urine Oxalate in Calcium Stone Formers with Hyperoxaluria: A Randomized, Placebo-controlled, Double-blind and In-vitro Trial.

PURPOSE: To determine the effect of a probiotic supplement containing native Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium animalis lactis (B. lactis) on 24-hour urine oxalate in recurrent calcium stone formers with hyperoxaluria. Moreover, the in-vitro oxalate degradation capacity and the intestinal colonization of consumed probiotics were evaluated. MATERIALS AND METHODS: The oxalate degrading activity of L. acidophilus and B. lactis were evaluated in-vitro. The presence of oxalyl-CoA decarboxylase (oxc) gene in the probiotic species was assessed. One hundred patients were randomized to receive the probiotic supplement or placebo for four weeks. The 24-hour urine oxalate and the colonization of consumed probiotics were assessed after weeks four and eight. RESULTS: Although the oxc gene was present in both species, only L. acidophilus had a good oxalate degrading activity, in-vitro. Thirty-four patients from the probiotic and thirty patients from the placebo group finished the study. The urine oxalate changes were not significantly different between groups (57.21 ± 11.71 to 49.44 ± 18.14 mg/day for probiotic, and 56.43 ± 9.89 to 50.47 ± 18.04 mg/day for placebo) (P = .776). The probiotic consumption had no significant effect on urine oxalate, both in univariable (P = .771) and multivariable analyses (P = .490). The consumed probiotics were not detected in the stool samples of most participants. CONCLUSION: Our results showed that the consumption of a probiotic supplement containing L. acidophilus and B. lactis did not affect urine oxalate. The results may be due to a lack of bacterial colonization in the intestine.

Probiotic and selenium co-supplementation, and the effects on clinical, metabolic and genetic status in Alzheimer's disease: A randomized, double-blind, controlled trial.

BACKGROUND AND AIMS: Combined probiotic and selenium supplementation may improve Alzheimer's disease (AD) by correcting metabolic abnormalities, and attenuating inflammation and oxidative stress. This study aimed to determine the effects of probiotic and selenium co-supplementation on cognitive function and metabolic status among patients with AD. METHODS: This randomized, double-blind, controlled clinical trial was conducted among 79 patients with AD. Patients were randomly assigned to receive either selenium (200 µg/day) plus probiotic containing Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum (2 × 109 CFU/day each) (n = 27), selenium (200 µg/day) (n = 26) or placebo (n = 26) for 12 weeks. RESULTS: Selenium supplementation, compared with the placebo, significantly reduced serum high sensitivity C-reactive protein (hs-CRP) (P < 0.001), insulin (P = 0.001), homeostasis model of assessment-insulin resistance (HOMA-IR) (P = 0.002), LDL-cholesterol (P = 0.04) and total-/HDL-cholesterol ratio (P = 0.004), and significantly increased total glutathione (GSH) (P = 0.001) and the quantitative insulin sensitivity check index (QUICKI) (P = 0.01). Compared with only selenium and placebo, probiotic and selenium co-supplementation resulted in a significant increase in mini-mental state examination score (+1.5 ± 1.3 vs. +0.5 ± 1.2 and -0.2 ± 1.1, respectively, P < 0.001). Probiotic plus selenium intake resulted in a significant reduction in hs-CRP (-1.6 ± 1.4 vs. -0.8 ± 1.0 and +0.1 ± 0.5 mg/L, respectively, P < 0.001), and a significant increase in total antioxidant capacity (+89.4 ± 129.6 vs. +20.0 ± 62.5 and -0.7 ± 27.2 mmol/L, respectively, P = 0.001) and GSH (+122.8 ± 136.5 vs. +102.2 ± 135.2 and +1.5 ± 53.2 µmol/L, respectively, P = 0.001) compared with only selenium and placebo. In addition, subjects who received probiotic plus selenium supplements had significantly lower insulin levels (-2.1 ± 2.5 vs. -1.0 ± 1.3 and +0.7 ± 2.0 µIU/mL, respectively, P < 0.001), HOMA-IR (-0.5 ± 0.6 vs. -0.2 ± 0.3 and +0.1 ± 0.4, respectively, P < 0.001), and higher QUICKI (+0.01 ± 0.01 vs. +0.005 ± 0.007 and -0.002 ± 0.01, respectively, P < 0.006) compared with only selenium and placebo. Additionally, probiotic and selenium co-supplementation resulted in a significant reduction in serum triglycerides (-17.9 ± 26.1 vs. -3.5 ± 33.9 and +0.3 ± 9.3 mg/dL, respectively, P = 0.02), VLDL- (-3.6 ± 5.2 vs. -0.7 ± 6.8 and +0.05 ± 1.8 mg/dL, respectively, P = 0.02), LDL- (-8.8 ± 17.8 vs. -8.1 ± 19.2 and +2.7 ± 19.0 mg/dL, respectively, P = 0.04) and total-/HDL-cholesterol (-0.3 ± 0.7 vs. -0.4 ± 0.9 and +0.3 ± 0.6, respectively, P = 0.005) compared with only selenium and placebo. CONCLUSIONS: Overall, we found that probiotic and selenium co-supplementation for 12 weeks to patients with AD improved cognitive function and some metabolic profiles. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT20170612034497N5).

The Effects of Synbiotic Supplementation on Carotid Intima-Media Thickness, Biomarkers of Inflammation, and Oxidative Stress in People with Overweight, Diabetes, and Coronary Heart Disease: a Randomized, Double-Blind, Placebo-Controlled Trial.

Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions. The aim of this study was to evaluate the effects of synbiotic supplementation on carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress in people with overweight, diabetes, and coronary heart disease (CHD). This randomized, double-blind, placebo-controlled trial was conducted and involved 60 people with overweight, diabetes, and CHD, aged 50-85 years old. Participants were randomly allocated into two groups to take either synbiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin or placebo (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention period to determine metabolic variables. After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 3101.7 ± 5109.1 vs. - 6.2 ± 3163.6 ng/mL, P = 0.02), plasma malondialdehyde (MDA) (- 0.6 ± 1.0 vs. - 0.1 ± 0.3 µmol/L, P = 0.01), and significantly increased nitric oxide (NO) levels (+ 7.8 ± 10.3 vs. - 3.6 ± 6.9 µmol/L, P < 0.001). We did not observe any significant changes of synbiotic supplementation on other biomarkers of oxidative stress and CIMT levels. Overall, synbiotic supplementation for 12 weeks among people with overweight, diabetes, and CHD had beneficial effects on serum hs-CRP, plasma NO, and MDA levels; however, it did not have any effect on other biomarkers of oxidative stress and CIMT levels.

The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial.

Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 µIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (- 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (- 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (- 0.05 ± 0.08 vs. - 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.

The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial.

This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 109 CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (ß - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (ß - 5.49 µIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (ß - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (ß 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (ß - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (ß - 0.60 µmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (ß 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (ß 131.11 µmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.

The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

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.

The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes.

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 × 109 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.

The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes.

Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidative actions. This study was designed to evaluate the effects of synbiotic administration on biomarkers of inflammation, oxidative stress, and pregnancy outcomes among gestational diabetic (GDM) women. This randomized, double-blind, placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), L. casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin (HPX) (n = 30) or placebo (n = 30) for 6 weeks. Compared with the placebo, synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 4.2 vs. +1.1 ± 3.5 mg/L, P = 0.004), plasma malondialdehyde (MDA) (- 0.1 ± 0.6 vs. + 0.3 ± 0.7 µmol/L, P = 0.02), and significantly increased total antioxidant capacity (TAC) (+ 70.1 ± 130.9 vs. - 19.7 ± 124.6 mmol/L, P = 0.009) and total glutathione (GSH) levels (+ 28.7 ± 61.5 vs. - 14.9 ± 85.3 µmol/L, P = 0.02). Supplementation with synbiotic had a significant decrease in cesarean section rate (16.7 vs. 40.0%, P = 0.04), lower incidence of hyperbilirubinemic newborns (3.3 vs. 30.0%, P = 0.006), and newborns' hospitalization (3.3 vs. 30.0%, P = 0.006) compared with the placebo. Synbiotic supplementation did not affect plasma nitric oxide (NO) levels and other pregnancy outcomes. Overall, synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP, plasma TAC, GSH, and MDA; cesarean section; incidence of newborn's hyperbilirubinemia; and newborns' hospitalization but did not affect plasma NO levels and other pregnancy outcomes. http://www.irct.ir : www.irct.ir : IRCT201704205623N108.

Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m2, p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 µIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.

Probiotic supplementation in diabetic hemodialysis patients has beneficial metabolic effects.

This study determined the effects of probiotic supplementation on glycemic control, lipid concentrations, biomarkers of inflammation and oxidative stress in 60 diabetic patients on hemodialysis in a parallel randomized double-blind placebo-controlled clinical trial. Participants were initially matched based on sex, duration of dialysis and diabetes, body mass index and age. Subsequently, they were randomly divided into two groups to take either a capsule containing the probiotics Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum or placebo for 12 weeks. Based on three-day dietary records throughout the trial, there was no significant change in dietary macro- and micro-nutrients or total dietary fiber to confound results. After the 12 weeks, analysis of patients who received probiotic supplements compared with the placebo showed they had significantly decreased fasting plasma glucose (-22.0 vs. +6.6 mg/dl), serum insulin (-6.4 vs. +2.3 µIU/ml), homeostasis model of assessment-estimated insulin resistance (-2.9 vs. +2.5), homeostasis model of assessment-estimated beta-cell function (-14.1 vs. +6.1) and HbA1c (-0.4 vs. -0.1%,), and improved quantitative insulin sensitivity check index (+0.03 vs. -0.02). Additionally, compared with the placebo, probiotic supplementation resulted in significant reductions in serum high-sensitivity C-reactive protein (-1933 vs. +252 ng/ml), plasma malondialdehyde (-0.3 vs. +1.0 µmol/l), subjective global assessment scores (-0.7 vs. +0.7) and total iron binding capacity (-230 vs. +33 µg/dl), and a significant increase in plasma total antioxidant capacity (+15 vs. -88 mmol/l). Thus, probiotic supplementation for 12 weeks among diabetic hemodialysis patients had beneficial effects on parameters of glucose homeostasis, and some biomarkers of inflammation and oxidative stress.

Clinical and metabolic response to probiotic supplementation in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled trial.

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.

Effects of Probiotic Supplementation on Metabolic Status in Pregnant Women: a Randomized, Double-blind, Placebo-Controlled Trial.

BACKGROUND: Limited data is available on the effects of multispecies probiotic supplementation on metabolic status in pregnant women in the first half of pregnancy. The current study was carried out to determine the effects of multispecies probiotic capsule supplementation on metabolic status among pregnant women in the first half of pregnancy. METHODS: A randomized clinical trial was conducted among 60 pregnant women aged 18-37 years. The participants were randomly divided into two groups: group A (n = 30) received multispecies probiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum (2 × 109 CFU/g each) and group B (n = 30) received placebo from 9 weeks of gestation for a duration of 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine metabolic profiles, inflammatory cytokines and biomarkers of oxidative stress. RESULTS: After 12 weeks of intervention, compared to the placebo group, the pregnant women who consumed probiotic capsule had significantly decreased serum insulin concentrations (-1.5 ± 4.8 vs. +1.3 ± 5.2 µIU/mL, P = 0.03), the homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-0.3 ± 0.9 vs. +0.3 ± 1.1, P = 0.04), the homeostasis model of assessment-estimated b cell function (HOMA-B) (-7.2 ± 23.1 vs. +5.3 ± 22.6, P = 0.03) and increased quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.05 vs. -0.01 ± 0.02, P = 0.03). In addition, changes in serum triglycerides levels (-14.7 ± 46.5 vs. +37.3 ± 74.2 mg/dL, P = 0.002), high-sensitivity C-reactive protein (hs-CRP) (-1.0 ± 2.6 vs. +1.7 ± 4.3 mg/L, P = 0.004), plasma nitric oxide (NO) (+6.8 ± 9.3 vs. -4.7 ± 7.4 µmol/L, P < 0.001), total antioxidant capacity (TAC) (+171.9 ± 187.6 vs. -51.9 ± 208.8 mmol/L, P < 0.001) and glutathione (GSH) concentrations (+34.3 ± 71.6 vs. -36.9 ± 108.3 µmol/L, P = 0.004) in supplemented women were significantly different from those of the placebo group. However, after controlling for baseline levels, age and BMI at the study baseline, the changes in plasma GSH were not significantly different between the groups. CONCLUSION: Overall, probiotic supplementation for 12 weeks among pregnant women in the first half of pregnancy had beneficial effects on markers of insulin metabolism, triglycerides, biomarkers of inflammation and oxidative stress.

Clinical and metabolic response to probiotic administration in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: We are aware of no study examining the effects of probiotic supplementation on symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress in patients with major depressive disorder (MDD). The present study was designed to determine the effects of probiotic intake on symptoms of depression and metabolic status in patients with MDD. METHODS: This randomized, double-blind, placebo-controlled clinical trial included 40 patients with a diagnosis of MDD based on DSM-IV criteria whose age ranged between 20 and 55 y. Patients were randomly allocated into two groups to receive either probiotic supplements (n = 20) or placebo (n = 20) for 8 wk. Probiotic capsule consisted of three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) CFU/g), Lactobacillus casei (2 × 10(9) CFU/g), and Bifidobacterium bifidum (2 × 10(9) CFU/g). Fasting blood samples were taken at the beginning and end of the trial to quantify the relevant variables. All participants provided three dietary records (two weekdays and one weekend) and three physical activity records during the intervention. RESULTS: Dietary intake of study participants was not significantly different between the two groups. After 8 wk of intervention, patients who received probiotic supplements had significantly decreased Beck Depression Inventory total scores (-5.7 ± 6.4 vs. -1.5 ± 4.8, P = 0.001) compared with the placebo. In addition, significant decreases in serum insulin levels (-2.3 ± 4.1 vs. 2.6 ± 9.3 µIU/mL, P = 0.03), homeostasis model assessment of insulin resistance (-0.6 ± 1.2 vs. 0.6 ± 2.1, P = 0.03), and serum hs-CRP concentrations (-1138.7 ± 2274.9 vs. 188.4 ± 1455.5 ng/mL, P = 0.03) were observed after the probiotic supplementation compared with the placebo. Additionally, taking probiotics resulted in a significant rise in plasma total glutathione levels (1.8 ± 83.1 vs. -106.8 ± 190.7 µmol/L, P = 0.02) compared with the placebo. We did not find any significant change in fasting plasma glucose, homeostatic model assessment of beta cell function, quantitative insulin sensitivity check index, lipid profiles, and total antioxidant capacity levels. CONCLUSIONS: Probiotic administration in patients with MDD for 8 wk had beneficial effects on Beck Depression Inventory, insulin, homeostasis model assessment of insulin resistance, hs-CRP concentrations, and glutathione concentrations, but did not influence fasting plasma glucose, homeostatic model assessment of beta cell function, quantitative insulin sensitivity check index, lipid profiles, and total antioxidant capacity levels.