Regulation of NLRP3 inflammasome by zinc supplementation in Behçet's disease patients: A double-blind, randomized placebo-controlled clinical trial.

BACKGROUND: Overproduction of NLRP3 inflammasome complex is one of the causes of Behcet's disease's (BD) auto-inflammatory nature. The aim of current study was to examine the effect of zinc supplementation on NLRP3 inflammasome expression; as well as clinical manifestations of BD. METHODS: In this double-blind parallel placebo-controlled randomized clinical trial, 50 BD patients were randomly allocated into either zinc gluconate (30 mg/day elemental zinc) or placebo groups for 12 weeks. The mRNA expression of NLRP3 and caspase-1 in the leukocytes, serum level of zinc and IL-1ß, anthropometric measures, and clinical manifestations of patients were collected at pre- and post-intervention phase. The Iranian Behçet's disease dynamic activity measure (IBDDAM) was scored to measure the treatment effect using the calculation of number needed to treat (NNT). Analysis of covariance was performed to obtain the corresponding effect sizes. RESULTS: Zinc gluconate led to a significant improvement in genital ulcer (P = 0.019). Zinc supplementation decreased NLRP3 and caspase-1 genes expression compared with placebo group (baseline-adjusted P-value = 0.046 for NLRP3 and P-value = 0.003 for caspase-1), even after adjustment for the effect of confounding factors (baseline- and confounders-adjusted P-value = 0.032 for NLRP3 and P-value = 0.004 for caspase-1). Baseline and confounders adjusted effect size demonstrated that zinc was effective in reducing the serum level of IL-1ß (P = 0.046). The NNT [95 %CI] for the rate of IBDDAM improvement was 3 [1.7-8.5]. CONCLUSIONS: Zinc gluconate supplementation (30 mg/day) for a 3-month period can be considered as an adjuvant therapy in alleviating inflammation and genital ulcer among BD patients.

Immunomodulatory and clinical responses to zinc gluconate supplementation in patients with Behçet's disease: A double-blind, randomized placebo-controlled clinical trial.

BACKGROUND & AIMS: Toll-like receptor (TLR) 2 and 4 are involved in the pathogenesis of Behçet's disease (BD). The current study aimed to investigate the effect of zinc supplementation on TLR-2/4 expression and the clinical manifestations of BD. METHODS: In this double-blind placebo-controlled randomized clinical trial, 50 BD patients were randomly allocated into either zinc gluconate (30 mg/day) or placebo groups for 12 weeks. Before and after the intervention, the surface and mRNA expression level of TLR-2 and TLR-4 in the leukocytes, serum level of zinc and tumor necrosis factor-α (TNF-α), quality of life, anthropometric measures, and blood pressure of patients were collected. BD activity was studied using the nonocular Iranian Behçet's disease dynamic activity measure (IBDDAM), Behçet's disease current activity form (BDCAF), and total inflammatory activity index (TIAI) at the pre-and post-intervention phases. The effect sizes were compared between two groups using analysis of covariance. RESULTS: There were significant decrease in TLR-2 mRNA (P = 0.038) and protein expression (P = 0.034) and nonocular IBDDAM score (P = 0.046) in the zinc group compared to placebo at the endpoint. The serum level of zinc was increased in the zinc group (P < 0.001). Zinc supplementation significantly decreased the TLR-4 surface (P = 0.012) and mRNA expression (P = 0.028) within the group. However, this decrease was not significant compared to the placebo group. There was no significant difference between the two groups regarding the serum level of TNF-α, BDCAF, TIAI, quality of life, anthropometric measures, and blood pressure (P > 0.05). CONCLUSIONS: The present study revealed that zinc supplementation significantly improved nonocular IBDDAM score and TLR-2 expression in BD patients. GOV REGISTRATION NUMBER: NCT05098678.

The Effect of ω3 Fatty Acids Supplementation on Levels of PPARγ and UCP2 Genes Expression, Serum Level of UCP2 Protein, Metabolic Status, and Appetite in Elite male Athletes: Protocol for a Randomized Control Trial.

Some genetic factors may influence body composition, such as PPARγ and UCP2. PPARγ plays an important role in body fat distribution. The objective of the present study is to determine the effects of omega3 fatty acids on the gene expression of PPARγ and UCP2, levels of blood lipid profile, fat mass, and fat-free mass, and appetite. Elite male athlete volunteers of up to 36 subjects were invited to participate in this RCT. Following a public announcement, volunteers were recruited from gyms, teams, and sports medicine boards in Tabriz, Iran. Gene's expression of PPARγ and UCP2, serum levels of blood lipid profile, fat mass, and fat-free mass was collected. Data collection time points include baseline in addition to 3 weeks follow up. The study was approved by the Ethics Committee of the Tabriz University Medical of Sciences (IR.TBZMED.REC.1398.782) in October 2019 and was registered with the Iranian Registry of Clinical Trials: 20190625044008N1 on December 19, 2019. Recruitment began in July and concluded in December 2019. As of August 19, 2019, we have screened 373 volunteers. 36 were enrolled. Baseline measurements of participants were collected. After three-week of intervention, end study measurements of participants were collected. The results are expected to be released in 2021. Participants have a median age of 21.86 (±3.15). The finding of this study showed Results showed PPARγ mRNA levels, and UCP2 mRNA and protein levels increased in the omega3 group (p < 0.05), as did REE (p < 0.05). Also, differences in the sensation of hunger or satiety were significant (p < 0.05). This study could result in the effects of omega-3 fatty acids on PPARγ, and UCP2 expressions, blood lipid profiles and body composition. In addition, the results of this trial can be used as baseline information for conducting further clinical and sport nutrition studies. TRIAL REGISTRATION: The trial was registered at the Iranian registry of the clinical trial website (www.irct.ir) as IRCT20190625044008N1 (https://en.irct.ir/trial/43332), registered at (19/12/2019). HIGHLIGHTS: Omega3 fatty acids as a ligand of metabolic-related genes, have a role in energy expenditure.Omega3 supplements effect on PPARγ and UCP2 mRNA expression as regulators of energy metabolismOmega3 supplements increased REE.Omega-3 supplementation could change the changes in body composition.For athletes, omega-3 simultaneously decreased fat mass and increased fat-mass.HDL-C increased after short-term supplementation with omega-3.Increased intake of omega-3, caused increased intake of energy and protein.

The effect of omega3 fatty acid supplementation on PPARγ and UCP2 expressions, resting energy expenditure, and appetite in athletes.

BACKGROUND: Omega3 fatty acids as a ligand of energy-related genes, have a role in metabolism, and energy expenditure. These effects are due to changes in the expression of peroxisome proliferator-activated receptor-gamma (PPARγ) and uncoupling protein2 (UCP2). This study evaluated the effect of omega3 supplements on PPARγ mRNA expression and UCP2 mRNA expression and protein levels, as regulators of energy metabolism, resting energy expenditure (REE), and appetite in athletes. METHODS: In a 3-week double-blind RCT in Tabriz, Iran, in 2019, 36 male athletes, age 21.86 (±3.15) y with 16.17 (±5.96)% body fat were randomized to either an intervention (2000 mg/day omega3; EPA: 360, DHA: 240) or placebo (2000 mg/day edible paraffin) groups. Appetite and REE were assessed before and after the intervention. PPARγ and UCP2 mRNA expression and UCP2 protein levels in blood were evaluated by standard methods. RESULTS: Results showed PPARγ mRNA levels, and UCP2 mRNA and protein levels increased in omega3 group (p < 0.05), as did REE (p < 0.05). Also, differences in the sensation of hunger or satiety were significant (p < 0.05). CONCLUSIONS: Our findings showed that omega3 supplementation leads to the up-regulation of PPARγ and UCP2 expressions as the indicators of metabolism in healthy athletes.

Daily consumption effects of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on oxidative stress in metabolic syndrome patients.

BACKGROUND AND AIMS: Available evidence substantiates a strong association between metabolic syndrome and elevated oxidative stress. This study was aimed to assess the effects of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on the oxidative stress biomarkers in patients with metabolic syndrome. Furthermore, the association between uric acid levels and insulin resistance indexes was assessed. METHODS: An 8-week randomized, double-blind, placebo-controlled, parallel study was designed. Forty-four patients, 22 males and 22 females aged 20-65 years, were assigned into two groups. Treatment (n = 22) and control (n = 22) groups consumed 300 g/d of probiotic and regular yogurt, respectively. The serum concentration of uric acid, oxidized Low-Density Lipoprotein (oxLDL), Malondialdehyde (MDA) and Total Antioxidant Capacity (TAC) were measured at the beginning and the end of the trial. This study was recorded at http://www.irct.ir (code: IRCT201608213140N17). RESULTS: Probiotic yogurt consumption resulted in a significant decrease in the level of serum uric acid and a significant increase in the level of TAC (p < 0.05). A positive significant association between uric acid with insulin concentration and the homeostasis model assessment of insulin resistance (HOMA-IR) and an inverse significant relationship with insulin sensitivity (Quicki) were also found (p < 0.05). CONCLUSION: Probiotic yogurt consumption through improvement in insulin sensitivity may exert positive effects on the oxidative stress and uric acid levels. However, further studies are needed to make concise conclusions.

Profiling inflammatory cytokines following zinc supplementation: a systematic review and meta-analysis of controlled trials.

Chronic inflammation has been considered as the main cause of chronic diseases. Zn has anti-inflammatory effects by decreasing the expression of inflammatory markers. The present systematic review and meta-analysis study aims to evaluate the impact of Zn supplementation on inflammation. PubMed (Medline), Scopus, Web of Science, and Embase databases were searched up to 10 December 2020. Controlled trials which have investigated the effects of Zn supplementation on serum/plasma levels of inflammatory cytokines in subjects aged >15 years were included. A pooled meta-analysis was performed using a random effect model. Sensitivity analysis was performed to determine the robustness of the observed effect sizes. A total of twelve studies was included in meta-analysis. Zn could decrease IL-6 levels (standardised mean difference (SMD) = -0·76 pg/ml; 95 % CI -1·28, -0·24; P = 0·004). There was no significant change in TNF-α (SMD = 0·42 pg/ml; 95 % CI -0·31, 1·16; P = 0·257) and IL-2 levels (SMD = 1·64 pg/ml; 95 % CI -1·31, 4·59; P = 0·277) following Zn supplementation. However, Zn could increase IL-2 significantly after the deletion of one arm in sensitivity analysis (SMD = 2·96 pg/ml; 95 % CI 2·03, 3·88; P < 0·05). Conclusively, Zn supplementation can decrease the IL-6 level. Zn increased IL-2 level after the sensitivity analysis. Zn supplementation has not ameliorative effects on TNF-α.

The associations between dietary pattern of chronic obstructive pulmonary disease patients and depression: a cross-sectional study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common lung disease during middle age which one of its complications is depression. Depression is considered one of the major causes of severe disability worldwide. One of the factors that affect the severity and incidence of this disease is a lifestyle, especially dietary pattern. On the other hand, some studies showed the relationship between dietary patterns and depression. The present study aims to investigate the dietary patterns of people with chronic obstructive pulmonary disease and its association with depression. METHODS: The present cross-sectional study was performed on 220 patients (mean ± SD age = 54.58 ± 5.08) with chronic obstructive pulmonary disease (56.6% men, 43.4% women) from Tabriz, Iran. Questionnaires of general information, food frequency, Beck depression and physical activity were completed. The dominant dietary patterns were determined by factor analysis, and their relationship with depression was discussed by regression analysis. RESULTS: Three dominant dietary patterns were identified as healthy, unhealthy, and mixed dietary patterns. An inverse relationship was found between healthy and mixed dietary patterns with depression. There is no meaningful connection between unhealthy dietary patterns and depression. Depression had a significant inverse relationship with physical activity. There was no relationship between dietary patterns and Forced Expiratory Volume for 1 s (FEV1) and Forced Vital Capacity (FVC) criteria. A positive and significant relationship was observed between mixed dietary patterns with FEV1/FVC. CONCLUSION: Inverse relationships exist between healthy dietary patterns and depression in patients with COPD, and improves the function of the lungs. Further studies are needed to show the exact relationship between diet and COPD depression.

Preventive and Tumor-Suppressive Effects of Lactobacillus Paracasei X12 in Rat Model of Colorectal Cancer.

The paper in hand seeks to evaluate the tumor-suppressive and apoptotic effects of L. paracasei X12 in 1, 2-dimethylhydrazine (DMH)-induced rat colon carcinogenesis. The rats were divided into three groups (n = 8-12 per group); L. paracasei X12 was administrated to these animals for forty weeks. The findings of this study indicated that L. paracasei X12 administration prevented severe weight loss in DMH-treated rats. It was also determined that L. paracasei X12 administration could prevent the neoplasia incidence, cell proliferation and it also could suppress the tumors' growth. Additionally, a significant improvement was observed in apoptosis indexes and cell proliferation in probiotic-treated rats. In conclusion, this study provides insights into the therapeutic potential of L. paracasei X12 with emphasis on the issue that modulation of apoptosis pathway could leave beneficial effects in the prevention and suppression of colorectal cancer (CRC). However, further studies are in support to clarify the mechanisms involved in the tumor-suppressive effect of probiotics.

Effects of probiotic yogurt on glycemic indexes and endothelial dysfunction markers in patients with metabolic syndrome.

OBJECTIVES: The relationship between gut microflora and metabolic syndrome components such as obesity, low-grade chronic systemic inflammation, dyslipidemia, and altered glucose metabolism is now acknowledged. The aim of this study was to assess the effects of probiotic yogurt on glycemic indexes and endothelial dysfunction markers in patients with metabolic syndrome. METHODS: This was a randomized, double-blind, placebo-controlled clinical trial of 44 patients with metabolic syndrome (22 men and 22 women), who were 20 to 65 y of age. The patients were assigned to either a treatment or control group and consumed 300g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or a regular yogurt for 2 mo, respectively. Each group contained 22 participants. Fasting blood glucose and serum insulin was performed to derive homeostasis model assessment of insulin resistance (HOMA-IR), insulin sensitivity (Quicki), and HOMA of ß-cell function (HOMA- ß). In addition, markers of vascular cell adhesion molecule cell (VCAM)-1, intercellular adhesion molecule cell (ICAM)-1, and plasminogen activator inhibitor (PAI)-1 were measured to evaluate endothelial function at the beginning and at the end of the study. RESULTS: Consumption of probiotic yogurt resulted in a significant reduction in the level of blood glucose and VCAM-1. Significant changes in PAI-1, VCAM-1, insulin, HOMA-IR, and Quicki were observed in the probiotic yogurt group after intervention compared with baseline. CONCLUSION: Consumption of probiotic yogurt improved fasting blood glucose and partly modified serum endothelial function markers. These results suggest that regular intake of probiotic yogurt may exert positive effects on the treatment of metabolic syndrome.

Probiotic assisted weight management as a main factor for glycemic control in patients with type 2 diabetes: a randomized controlled trial.

OBJECTIVES: To evaluate the effect of Lactobacillus casei 01 on dietary intake, body weight, and glycemic control in patients with T2DM. METHOD: Forty patients with T2DM (n = 20 for each group) were assigned into two groups in present trial. The patients in the probiotic group received a daily capsule containing a minimum of 108 CFU of L. casei 01 for 8 week. The placebo group took capsules filled with maltodextrin for the same time period. Dietary intake questionnaires and anthropometric measurements were collected, and the participants were assessed by an endocrinologist at baseline and at the end of the trial. RESULTS: Lactobacillus casei 01 supplementation significantly decreased total energy, carbohydrate, fat, and protein intake compared with placebo (p = 0.001, p = 0.002, p = 0.009, p = 0.001; respectively). Moreover weight, BMI, and waist circumference were significantly decreased in intervention group compared with placebo group (p < 0.001; p < 0.001; p = 0.029; respectively). In comparison with placebo group serum fetuin-A level, fasting blood sugar, insulin concentration, and insulin resistance were significantly decreased (p = 0.023, p =0.013, p = 0.028; p = 0.007; respectively), and serum SIRT1 level was significantly increased (p = 0.040) in intervention group. CONCLUSIONS: Lactobacillus casei 01 supplementation affected dietary intake and body weight in a way that improved fetuin-A and SIRT1 levels and glycemic response in subjects with T2DM. Affecting the fetuin-A and SIRT1 levels introduces a new known mechanism of probiotic action in diabetes management.

The Effects of Lactobacillus casei on Glycemic Response, Serum Sirtuin1 and Fetuin-A Levels in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Background: Type 2 diabetes mellitus (T2DM) is related to the gut microbiota with numerous molecular mechanisms. Modulating the gut microbiota by probiotics could be effective in management of T2DM. The aim of the present trial was to evaluate the effect of Lactobacillus casei on glycemic control and serum sirtuin1 (SIRT1) and fetuin-A in patients with T2DM. Methods: Forty patients with T2DM (n = 20 for each group) were divided into intervention (probiotic) and placebo groups. The intervention group received a daily capsule containing 108 cfu of L. casei for eight weeks. The patients in placebo group took capsules containing maltodextrin for the same time duration. Anthropometric measurements, dietary intake questionnaires, and blood samples were collected, and the patients were assessed by an endocrinologist at the beginning and at the end of the trial. Results: Fasting blood sugar, insulin concentration, and insulin resistance significantly decreased in probiotic group compared with placebo group (-28.32 [-50.23 to -6.41], 0.013; -3.12 [-5.90 to -0.35], 0.028; -32.31 [-55.09 to -9.54], 0.007, respectively). Moreover, HbA1c reduced after intervention, but the reduction was not significant (-0.45 [-0.96 to 0.05], 0.077). In comparison with placebo, the L. casei supplementation significantly increased SIRT1 and decreased fetuin-A levels at the end of the trial (0.52 [0.026 to 1.02], 0.040; -17.56 [-32.54 to -2.58], 0.023, respectively). Conclusion: L. casei supplementation affected SIRT1 and fetuin-A levels in a way that improved glycemic response in subjects with T2DM. Affecting the SIRT1 and fetuin-A levels introduces a new known mechanism of probiotic action in diabetes management.

Effects of probiotic supplementation on lipid profile of women with rheumatoid arthritis: A randomized placebo-controlled clinical trial.

Background: Probiotics are live beneficial microorganisms which may exert hypolipidemic effects through many mechanisms. Lipid profile disturbances are frequently reported in rheumatoid arthritis (RA) patients. The objective of this study was to evaluate the effects of Lactobacillus casei on serum lipids of RA women. Methods: In the present parallel randomized double-blind placebo-controlled clinical trial, 60 RA patients were recruited and divided into 2 groups. They received either a daily capsule containing 108 CFU of L. casei 01, or identical capsules containing maltodextrin, for 8 weeks. Anthropometric parameters, dietary intake and physical activity were assessed at 2 ends of the study. Serum levels of total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C) and triglyceride (TG) were measured. Independent-samples t test and analysis of covariance (ANCOVA) test, and paired t test were used to test between- and within-group differences, respectively. Results: There were no significant between- or within-group differences for demographic and anthropometric parameters, physical activity and dietary intakes, throughout the study. No statistically significant within-group changes were observed for serum lipids in either group; between-group differences were also insignificant by the end of study period (TC: -0.18 [-0.65, 0.29], P = 0.801, HDL-C: -1.66 [-19.28, 15.59], P = 0.663, LDL-C: -2.73 [-19.17, 13.73], P = 0.666, TG: 0.12 [-19.76, 20.00], P = 0.900). Conclusion: Lactobacillus casei 01 could not improve serum lipids in RA patients. Further studies using probiotic foods and different probiotic strains are suggested.

Effects of Probiotic Supplementation on Oxidative Stress Indices in Women with Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial.

OBJECTIVE: Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that causes great pain and disability and increasing oxidative stress in patients. The objective of the present study was to evaluate the effects of probiotics-live microorganisms with many health benefits, including antioxidant properties-on oxidative stress indices of patients with RA. This study is a secondary analysis from a previously published study Methods: In a randomized double-blind placebo-controlled clinical trial, 46 patients with RA were assigned to one of two groups; patients in the probiotic group received a daily capsule containing 10(8) colony forming units (CFUs) of Lactobacillus casei 01 (L. casei 01), while those in the placebo group took identical capsules containing maltodextrin, for 8 weeks. In the baseline and at the end of the study, anxiety, physical activity levels, and dietary intakes were assessed. Anthropometric parameters, serum malondialdehyde (MDA), total antioxidant capacity (TAC), erythrocyte superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT) activities were measured. RESULTS: There was no significant difference between the two groups for demographic characteristics, anthropometric parameters, physical activity, anxiety levels, or dietary intakes, throughout the course of the study. No significant within- and between-group differences were observed for MDA, TAC, or CAT. SOD activity decreased only in the probiotic group and GPx activity decreased in both study groups (p < 0.05); however, no significant between-group difference was found for these enzymes activities at the end of the study (p > 0.05). CONCLUSION: No significant effect of L. casei 01 supplementation was observed on the oxidative status of patients with RA, compared to placebo.

Body image perception and its association with body mass index and nutrient intakes among female college students aged 18-35 years from Tabriz, Iran.

PURPOSE: Recent studies have shown that body image perception is an important factor in weight management and can be influenced by several social or cultural factors in Western or non-Western societies; however, body image perception and its nutritional and demographic determinants in Iran have not been extensively studied. In the current study, we aimed to evaluate body image perception and its socio-demographic and nutritional determinants among female university students in Tabriz City of Iran. METHODS: In the current cross-sectional survey, 184 female students aged 18-35 years from Tabriz, Iran, were enrolled. Anthropometric variables including weight, height, waist and hip circumference were measured and body mass index (BMI) and waist to hip ratio (WHR) were calculated. Body image perception and distortion were assessed by Figure Rating Scale (FRS) developed by Stunkard consisting of nine silhouettes. Nutrition intake was assessed by a 3-day 24-h dietary recall method and analyzed by Nutritionist IV software. RESULTS: Most of the participants in the underweight (41.66%), normal weight (67.71%) and overweight (57.14%) categories of BMI selected the thinnest figure as their desirable or ideal body image perception. The total prevalences of body image dissatisfaction and distortion were 51.63% and 64.13%, respectively. Subjects who had undistorted body image perception consumed more time for physical activity and had more night sleeping hours compared with others (P < 0.05). Subjects who perceived themselves as being of normal weight had significantly lower intake of total fat and saturated fatty acids and higher intakes of monounsaturated fatty acids (MUFAs) compared with other groups (P < 0.05). CONCLUSIONS: According to our findings, female participants had a higher tendency to consider thinness as the preferred body image style. Persons with undistorted body image perception had healthy nutritional status compared with others. Due to high prevalence of body image dissatisfaction, the need for appropriate interventional programs to prevent the associated co-morbidities is emphasized.

Effects of Lactobacillus casei supplementation on disease activity and inflammatory cytokines in rheumatoid arthritis patients: a randomized double-blind clinical trial.

AIM: The present study aimed at investigating the effects of Lactobacillus casei 01 supplementation on symptoms and inflammatory biomarkers of rheumatoid arthritis (RA) in women. METHOD: In this randomized double-blind clinical trial, female patients with established RA for more than 1 year, 20-80 years of age and body mass index (BMI) lower than 40, who followed stable medication for 3 months prior to the supplementation, were randomly allocated to receive either one capsule containing 10(8) colony forming units (CFU) of L. casei 01, or a placebo for 8 weeks; allocation was stratified by BMI and menopausal status. Disease activity score-28 (DAS28) was calculated, European League Against Rheumatism (EULAR) response was evaluated and the cytokines, interleukin (IL)-1ß, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-α were measured. RESULTS: Thirty patients were recruited in each group; 22 and 24 patients were analyzed in the probiotic and placebo groups, respectively. L. casei 01 supplementation decreased serum high-sensitivity C-reactive protein (hs-CRP) levels, tender and swollen joint counts, global health (GH) score and DAS28 (P < 0.05). More patients in the L. casei 01 group had moderate response to the treatment, based on the EULAR criteria, at the end of the study (P < 0.01). At the end of the study, a significant difference was observed between the two groups for IL-10, IL-12 and TNF-α changes through the study course (P < 0.05), in favor of the probiotic group. No adverse effects were reported for the intervention. CONCLUSION: Probiotic supplementation may be an appropriate adjunct therapy for RA patients and help alleviate symptoms and improve inflammatory cytokines.

Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis.

OBJECTIVES: Rheumatoid arthritis (RA) is an inflammatory autoimmune disease in which the gut microbiota is altered. Probiotics are microorganisms that can normalize gut microbiota; thus, they may help to alleviate RA symptoms. The objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with RA. METHODS: Forty-six patients with RA were assigned into two groups in this randomized, double-blind, placebo-controlled clinical trial. The patients in the probiotic group received a daily capsule that contained a minimum of 10(8) colony-forming units of Lactobacillus casei 01 for 8 wk. The placebo group took capsules filled with maltodextrin for the same time period. Questionnaires, anthropometric measurements, and fasting blood samples were collected, and the participants were assessed by a rheumatologist at baseline and at the end of the trial. RESULTS: Disease activity score was significantly decreased by the intervention, and there was a significant difference between the two groups at the end of the study (P < 0.01). Three of the assessed serum proinflammatory cytokines (tumor necrosis factor-α, interleukin-6, and interleukin-12) significantly decreased in the probiotic group (P < 0.05); however, serum levels of interleukin-1 ß were not significantly affected by the probiotic (P = 0.22). The serum level of regulatory cytokine (interleukin-10) was increased by the supplementation (P < 0.05). The proportion of interleukin-10 to interleukin-12 was significantly increased in the probiotic group as well. CONCLUSIONS: L. casei 01 supplementation improved the disease activity and inflammatory status of patients with RA. Further studies are warranted to confirm these results, and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population.