Effect of nano-curcumin supplementation on cardiometabolic risk factors, physical and psychological quality of life, and depression in patients with coronary slow flow phenomenon: a randomized double-blind clinical trial.

BACKGROUND: Extensive evidence has suggested the cardio-protective properties of the polyphenol curcumin. The aim of this study was to investigate the effects of a highly bioavailable curcumin supplement on cardiometabolic risk factors, health-related quality of life, and depression in patients with coronary slow flow phenomenon (CSFP). METHODS: This randomized double-blind placebo-controlled clinical trial was conducted in 42 patients with CSFP (age 35-70 years, 25 ≤ body mass index < 40 kg/m2). Patients received either 80 mg/day nano-curcumin or placebo for 12 weeks. Serum levels of visfatin, high-sensitivity C-reactive protein (hs-CRP), and glycemic indices were measured before and after the intervention. The short form 36-item quality of life (SF-36) and Beck's Depression Inventory-II (BDI-II) questionnaires were assessed, as well. RESULTS: No significant improvements were observed in circulating hs-CRP and visfatin following the intervention. A significant increase was observed in pre- to post-fasting blood glucose (- 0.9 ± 12.2 vs. 7.7 ± 12.4 mg/dl, p = 0.02) and hemoglobin A1C (- 0.1 ± 0.8 vs. 0.5 ± 0.8%, p = 0.04) levels, in the placebo compared with the intervention group. Physical (8.2 ± 8.1 vs. - 1.2 ± 6.5, p < 0.001) and mental (6.8 ± 11.8 vs. - 1.1 ± 10.4, p = 0.02) component summary scores were significantly improved in the nano-curcumin than the placebo group. Additionally, the number of patients with lower degrees of depression was significantly better in the intervention than the placebo group following the supplementation (p = 0.046). CONCLUSION: Curcumin supplementation prevented deterioration of glycemic control and improved physical and psychological quality of life and depression in patients with CSFP. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20131125015536N8), June 19, 2019.

Effects of virgin coconut oil consumption on serum brain-derived neurotrophic factor levels and oxidative stress biomarkers in adults with metabolic syndrome: a randomized clinical trial.

BACKGROUND AND AIM: Metabolic syndrome is associated with health conditions and neurological disorders. Brain-derived neurotrophic factor (BDNF) plays a protective role on the nervous system. Decreased levels of BDNF have been shown in MetS and neurodegenerative diseases. There is promising evidence regarding the anti-inflammatory antioxidant, and neuroprotective properties of virgin coconut oil (VCO). The aim of this study was to evaluate the effects of VCO consumption on serum BDNF levels, oxidative stress status, and insulin resistance in adults with MetS. METHODS: This randomized controlled clinical trial was conducted on 48 adults with MetS aged 20-50 years. The intervention group received 30 ml of VCO daily to substitute the same amounts of oil in their usual diet. The control group continued their usual diet. Serum BDNF levels, total antioxidant capacity (TAC), malondialdehyde (MDA) as well as HOMA-IR and QUICKI index were measured after four weeks of intervention. RESULTS: VCO consumption significantly reduced serum levels of MDA (p = .01), fasting insulin (p < .01) and HOMA-IR index (p < .01) and increased serum TAC (p < .01) and QUICKI index (p = .01) compared to the control group. Serum BDNF levels increased significantly in VCO group compared to the baseline (p = .02); however, this change was not significant when compared to the control group (p = .07). CONCLUSION: VCO consumption improved oxidative stress status and insulin resistance and had a promising effect on BDNF levels in adults with MetS. Further studies are needed to understand the long-term effects of VCO consumption.

Effects of hydrolyzed collagen alone or in combination with fish oil on the gut microbiome in patients with major burns.

Burns are associated with gut dysbiosis. Collagen peptides and omega-3 fatty acids (FAs) are suggested to improve wound healing and the inflammatory response. These are also correlated with microbiome colonization. Therefore, the present study aimed to investigate the effect of hydrolyzed collagen alone or in combination with fish oil on specific species of the gut microbiome in patients with major burns. In this randomized double-blind clinical trial, 57 adults (aged 18-60 years) with 20-45% total body surface area burns were randomised into three groups to receive either 40 gr hydrolyzed collagen +10 ml sunflower oil, 40 g hydrolyzed collagen +10 ml fish oil or placebo, divided into two daily drinks, for two weeks. Gut bacteria were measured using the real-time quantitative polymerase chain reaction (qPCR) method. The mean concentration of Bifidobacterium was significantly reduced in the control (P = 0.002) and collagen (P = 0.005) groups compared with the baseline values, whereas no significant change was observed in the collagen omega-3 group. The Firmicutes to Bacteroidetes ratio decreased significantly in the collagen group (p = 0.002) after supplementation compared to baseline . No significant changes in concentration of Lactobacillus, Enterobacteriaceae, and F.prausnitzii were observed between or within the study groups. Two weeks of supplementation with collagen and omega-3 FAs in patients with major burns did not result in a significant difference in the concentration of bacteria measured between the study groups. However, the addition of omega-3 FAs prevented a significant reduction in gut Bifidobacterium. Future studies are suggested to investigate the potential efficacy of these nutrients in improving the gut microbiota and clinical outcomes in major burns. REGISTRATION NUMBER: IRCT20131125015536N9.

Effects of oleoylethanolamide supplementation on the expression of lipid metabolism-related genes and serum NRG4 levels in patients with non-alcoholic fatty liver disease: A randomized controlled trial.

BACKGROUND: This study investigated the effects of oleoylethanolamide (OEA) supplementation on the expression levels of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α and CEBP-ß genes and serum neuregulin 4 (NRG4) levels in patients with non-alcoholic fatty liver diseases (NAFLD). METHODS: Sixty obese patients with NAFLD were equally allocated into either OEA or placebo group for 12 weeks. The mRNA expression levels of genes were determined using the reverse transcription polymerase chain reaction (RT-PCR) technique. Serum NRG4 level was also assessed using an enzyme-linked immunosorbent assay (ELISA) kit. RESULTS: At the endpoint, mRNA expression levels of SIRT1(p = 0.001), PGC-1α (p = 0.011) and AMPK (p = 0.019) were significantly higher in the OEA group compared to placebo group. However, no significant differences were observed in the expression levels of PPAR-γ, CEBP-α and CEBP-ß between the two groups. Serum NRG4 levels significantly increased in the OEA group compared with the placebo group after controlling for confounders (p = 0.027). In the OEA group, significant relationships were found between percent of changes in the expression levels of the SIRT1, AMPK and PGC-1α as well as serum NRG4 level with percent of changes in some anthropometric measures. Moreover, in the intervention group, percent of changes in high-density lipoprotein cholesterol was positively correlated with percent of changes in the expression levels of the SIRT1 and AMPK. While, percent of changes in triglyceride was inversely correlated with percent of changes in the expression levels of SIRT1. CONCLUSION: OEA could beneficially affect expression levels of some lipid metabolism-related genes and serum NRG4 level. "REGISTERED UNDER IRANIAN REGISTRY OF CLINICAL TRIALS IDENTIFIER NO: IRCT20090609002017N32".

Effect of Collagen Hydrolysate and Fish Oil on High-Sensitivity C-Reactive Protein and Glucose Homeostasis in Patients with severe Burn; a Randomized Clinical Trial.

INTRODUCTION: Collagen and omega-3 fatty acids (FAs) are suggested to have anti-inflammatory, anti-oxidant, and insulin-sensitizing properties. The aim of this study was to investigate the effect of collagen hydrolysate and omega-3 FAs on inflammation and insulin resistance in patients with major burns. METHODS: In this double-blind randomized clinical trial, 66 patients with 20-45% burns were assigned to either of the three groups of collagen (40 gr/d), collagen (40 gr/d) plus fish oil (10 ml/d), or control. High-sensitivity C-reactive protein (hs-CRP), fasting blood glucose (FBG) and insulin concentrations, and homeostatic model assessment for insulin resistance (HOMA-IR) were assessed at baseline, as well as end of weeks two and three. RESULTS: Based on post-hoc analyses, hs-CRP levels were significantly lower in the collagen (p=0.026) and collagen+omega-3 (p=0.044) groups compared to the control group, at week three. However, pre- to post- (week three) changes of hs-CRP were significantly higher only in the collagen+omega-3 group compared to the control group (173.2 vs. 103.7 mg/l, p=0.024). After three weeks of the intervention, insulin (11.3 and 11.9 vs. 22.8 µIU/ml) and HOMA-IR (2.9 and 2.8 vs. 7.9) values seemed to be clinically, but not statistically, lower in both intervention groups compared to the control group. Pre- to post- (week three) values of FBG decreased significantly in the collagen (p=0.002) and collagen+omega-3 (p=0.036) groups. Insulin (p=0.008) and HOMA-IR (p=0.001) decreased significantly only in the collagen+omega-3 group at week three compared to the baseline. CONCLUSIONS: Supplementation with collagen hydrolysate and omega-3 FAs can improve hs-CRP concentration and probably insulin resistance in patients with severe burns. Omega-3 FAs had additional effects on modulating inflammation. Larger clinical trials are needed to confirm the current findings especially in terms of glucose homeostasis.

Effects of curcuminoids on inflammatory and oxidative stress biomarkers and clinical outcomes in critically ill patients: A randomized double-blind placebo-controlled trial.

Experimental studies have suggested the beneficial effects of curcuminoids as natural polyphenols against traumatic brain injury (TBI). The aim of this study was to investigate the effects of supplementation with curcuminoids on inflammatory and oxidative stress biomarkers, clinical outcomes and nutritional status in critically ill patients with TBI. A total of 62 ICU-admitted adult patients with TBI were randomly allocated to receive either a daily dose of 500 mg curcuminoids or matched placebo via enteral nutrition for 7 consecutive days based on stratified block randomization by age and sex. Inflammatory and oxidative stress as well as clinical outcomes and nutritional status of the patients were measured at baseline and at the end of the study. There were no overall group effects regarding to all dependent variables. Compared with baseline, serum levels of IL-6, TNF-α, MCP-1 and CRP were significantly reduced in patients receiving curcuminoids (p < .05) without any significant changes in placebo group; however, changes in the activities of GPx and SOD in serum were not significant between two groups. Moreover, APACHEII and NUTRIC score were significantly improved following curcuminoids consumption in comparison with placebo (p < .05). The findings of this study suggest that short-term supplementation with curcuminoids may have beneficial effects on inflammation, clinical outcomes and nutritional status of critically ill patients with TBI.

White adipose tissue browning in critical illness: A review of the evidence, mechanisms and future perspectives.

Observational studies suggest better clinical outcomes following critical illness in patients with overweight and obesity (obesity paradox). An understanding of the morphologic, physiologic and metabolic changes in adipose tissue in critical illness may provide an explanation. Recent studies have demonstrated the transformation of white to brown-like adipocytes due to the "browning process," which has been of interest as a potential novel therapy in obesity during the last decade. The characteristics of the browning of white adipose tissue (WAT) include the appearance of smaller, multilocular adipocytes, increased UCP1 mRNA expression, mitochondrial density and respiratory capacity. These changes have been identified in some critical illnesses, which specifically refers to burns, sepsis and cancer cachexia in this study. The pathophysiological nature of WAT browning, underlying mechanisms, main regulators and potential benefits and harms of this process are interesting new areas that warrants further investigations. In this review, we discuss emerging scientific discipline of adipose tissue physiology in metabolic stress, available data, gaps of knowledge and future perspectives. Future investigations in this field may provide insights into the underlying mechanisms and clinical aspects of browning that may further our understanding of the proposed obesity paradox following critical illness, which may in turn open up opportunities for novel therapies to save lives and improve recovery.

The effect of synbiotics supplementation on anthropometric indicators and lipid profiles in women with polycystic ovary syndrome: a randomized controlled trial.

BACKGROUND: Different therapies have been suggested for polycystic ovary syndrome (PCOS), but changes in lifestyle and diet have been considered. Diet and dietary factors can be very effective in modifying the disease. The positive effects of probiotic and synbiotics supplementation on improving lipid profiles and anthropometric indices have been examined in various diseases. This study was conducted to evaluate the effects of synbiotics supplementation on lipid and anthropometric profiles in infertile women with PCOS. METHODS: PCOS patients aged 19-37 years old were randomized to receive either synbiotics supplement (n = 50) or placebo (n = 49) for 12 weeks. RESULTS: Consumption of synbiotics compared to the placebo, resulted in a significant decrease in Low-density lipoprotein cholesterol (LDL) value (Change Mean Difference (CMD): 4.66, 95%CI: 0.20, 9.13) and a significant increase in high-density lipoprotein cholesterol (HDL) (CMD: 1.80, 95%CI: 0.34, 3.26). Although we failed to find a significant effect of synbiotics consumption on total cholesterol (TC) and triglyceride (TG) levels. We did not find differences in anthropometric indices between groups. CONCLUSIONS: Overall, 12 weeks of synbiotics supplementation among PCOS women resulted in beneficial effects on LDL and HDL, although it is not yet clear how much our findings are clinically significant and more clinical studies with larger sample sizes are still needed. TRIAL REGISTRATION: Iranian Registry of clinical Trial, IRCT.ir, ID: IRCT2014110515536N2. Registered on 19 December 2015.

Effect of fish oil on circulating asymmetric dimethylarginine and adiponectin in overweight or obese patients with atrial fibrillation.

Obesity and adipose-derived peptides might be involved in the pathogenesis of atrial fibrillation (AF). Adiponectin plays a major role in the modulation of several metabolic pathways, and asymmetric dimethylarginine (ADMA) has been suggested to be predictive of AF and associated adverse events. The aim of this study was to investigate the effect of fish oil supplementation on circulating adiponectin and ADMA in overweight or obese patients with persistent AF. In this randomized, double-blind, placebo-controlled trial, 80 overweight or obese (body mass index (BMI) ≥ 25 kg/m2) patients with persistent AF were randomly assigned to two groups to receive either 2 g/day fish oil or placebo, for 8 weeks. Serum levels of adiponectin and ADMA, and anthropometric indexes were measured. This study showed that serum adiponectin concentrations increased significantly following fish oil supplementation compared with the placebo group (13.15 ± 7.33 vs. 11.88 ± 6.94 µg/ml; p = .026). A significant reduction was also observed in serum ADMA levels in the fish oil compared with the placebo group following the intervention (0.6 ± 0.13 vs. 0.72 ± 0.15 µmol/L; p = .001). The changes in serum adiponectin and ADMA concentrations remained significant after adjustments for baseline values, age, sex, and changes of BMI and waist circumference (p = .011 and p = .001, respectively). In conclusion,  8 weeks supplementation with fish oil increased serum adiponectin and decreased ADMA concentrations in overweight or obese patients with persistent AF. As adiponectin and ADMA are suggested to be involved in many pathways associated with AF, the current findings might be promising in the clinical management of this disease, an issue that needs further investigations.

Oleoylethanolamide supplementation in obese patients newly diagnosed with non-alcoholic fatty liver disease: Effects on metabolic parameters, anthropometric indices, and expression of PPAR-α, UCP1, and UCP2 genes.

The effects of oleoylethanolamide (OEA) on NAFLD are yet to be examined in human. The objective of the present study was to examine the effects of OEA supplementation along with weight loss intervention on the expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices among obese patients with NAFLD. In this triple-blind placebo-controlled randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group along with calorie-restricted diets for 12 weeks. At pre-and post-intervention phase, mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations were assessed. There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint. A significant decrease in the anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration was also observed in the OEA group, compared to the placebo group. OEA treatment significantly resulted in decreased serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations. Importantly, a significant improvement in TG, ALT, AST, ALT/AST, HDL-C levels as well as appetite sensations by OEA were under the influence of body mass index (BMI). Although liver steatosis severity was significantly reduced in both groups, the between-group differences did not reach statistical significance (P = 0.061). In conclusion, the present study, for the first time, revealed that OEA supplementation significantly improved anthropometric and metabolic risk factors related to NAFLD.

Vitamin D decreases CD40L gene expression in ulcerative colitis patients: A randomized, double-blinded, placebo-controlled trial.

BACKGROUND/AIMS: The interaction of CD40 ligand (CD40L) and CD40 triggers the induction of pro-inflammatory cytokines. It has been proposed that vitamin D deficiency might be an important factor, which causes or aggregates the autoimmune situations. The aim of the present study was to assess the effect of vitamin D on CD40L gene expression in patients with ulcerative colitis (UC). MATERIALS AND METHODS: Ninety mild-to-moderate UC patients were randomized to receive a single injection of 7.5 mg cholecalciferol or 1 mL normal saline. At baseline and 90 days following the intervention, RNA samples from whole blood were obtained. Fold changes in CD40L mRNA expression were determined for each patient using the 2-ΔΔCq method. The data were analyzed. RESULTS: The serum levels of vitamin D and calcium increased only in the vitamin D group (p<0.05). Relative to baseline values, the CD40L gene expression fold change was significantly lower in the vitamin D group compared with the placebo group (median±interquartile range: 0.34±0.30 vs 0.43±1.20, respectively, p=0.016). CONCLUSION: The results of this study showed that vitamin D administration in mild-to-moderate UC patients led to the downregulation of the CD40L gene, which is an essential part of inflammatory pathways.

Vitamin D suppresses proangiogenic factors in patients with ulcerative colitis: A randomized double blind placebo controlled clinical trial.

BACKGROUND: Angiogenesis and inflammation are involved in the pathogenesis of ulcerative colitis (UC). This study aimed to assess the effect of vitamin D on serum levels of proangiogenic factors, visfatin and vascular endothelial growth factor (VEGF), in patients with UC. MATERIALS AND METHODS: Ninety patients were randomized to receive either a single intramuscular injection of 300,000 IU vitamin D or normal saline. Visfatin, VEGF, and 25-hydroxyvitamin D [25(OH)D] concentrations were assessed before and 90 days after the intervention. RESULTS: There were no significant differences in visfatin and VEGF levels between the two groups following supplementation. In patients with vitamin D insufficiency, visfatin increase was significantly lower in the intervention versus placebo group. There was an inverse correlation between serum 25(OH)D and visfatin in the subgroup with vitamin D insufficiency. CONCLUSION: Vitamin D might be beneficial in decreasing proangiogenic factors such as visfatin in UC patients with low 25(OH)D levels.

Effects of Selenium Supplementation on Asymmetric Dimethylarginine and Cardiometabolic Risk Factors in Patients with Polycystic Ovary Syndrome.

Polycystic ovary syndrome (PCOS) is characterized by various reproductive and cardiometabolic disorders. Asymmetric dimethylarginine (ADMA) is associated with cardiovascular, metabolic, and hormonal status. Selenium, a micronutrient with antioxidant properties, could affect multiple physiological pathways. This study aimed to investigate the effect of selenium supplementation on ADMA, cardiometabolic risk factors, and hormonal status in women with PCOS. In this randomized, double-blind, placebo-controlled clinical trial, 66 women with PCOS, aged 18-45 years, were randomly assigned to receive either 200 µg/day selenium or placebo, for 12 weeks. Circulating concentrations of ADMA, testosterone, sex hormone-binding globulin (SHBG), lipid profiles, and glycemic parameters were assessed at baseline and following supplementation. ADMA concentration decreased significantly compared to baseline values (85.14 ± 75 to 56.4 ± 38.64 ng/l, p = 0.02) in the selenium group. This change was marginally significant compared with the placebo group (28.74 ± 68.63 vs. - 1.77 ± 52.88 ng/l, p = 0.056). Serum testosterone levels declined significantly in the intervention compared to the placebo group (0.01 ± 0.17 vs. - 0.08 ± 0.18 ng/ml, p = 0.038). Pre- to post-Apo-B100/Apo-A1 ratio declined considerably in the intervention group (0.72 ± 0.16 to 0.65 ± 0.16, p = 0.003). No further differences were observed in SHBG, lipid profiles, Apo-A1, Apo-B100, Apo-B100/Apo-A1 ratio, and glycemic control between the two groups at the end of the study. Selenium supplementation for 12 weeks had beneficial effects on reduction of circulating ADMA and total testosterone levels in women with PCOS. No significant improvements were seen in other cardiometabolic risk factors. The effects of selenium supplementation on hormonal, reproductive, and cardiometabolic disorders, considering the potential mediating role of ADMA, should be further investigated.

Therapeutic effects of supplementation with Curcuminoids in critically ill patients receiving enteral nutrition: a randomized controlled trial protocol.

BACKGROUND: Curcuminoids are dietary polyphenols that can improve health indices through different mechanisms such as anti-inflammatory, antioxidant and immunoregulatory properties. Due to the lack of evidences on the efficacy of curcuminoids in critically ill patients, this study was designed to investigate the effects of short-term curcuminoids supplementation on inflammatory, oxidative stress and adipokine indices as well as nutritional and clinical status in Traumatic Brain Injury (TBI) patients admitted in the Intensive Care Unit (ICU). METHODS: The present trial will be performed in the ICU of Sina and Shohadaye Tajrish hospitals of Tehran, Iran. Sixty-two critically ill patients with TBI will be enrolled based on the eligibility criteria. The patients will be randomly assigned into two groups. For 7 days, they will received either 500 mg curcuminoids in combination with 5 mg piperine or matched placebo. A general questionnaire, consent form as well as NUTRIC, SOFA and APACHEII scoring system and anthropometrics will be assessed at baseline. The inflammatory markers including TNF-α, IL-6, MCP-1 and CRP, oxidative stress indices (GPx and SOD) and adipokines (leptin and adiponetctin) will be measured at baseline and at the end of the study. In addition, dietary intake, concomitant drugs and laboratory tests will be recorded daily. DISCUSSION: To the best of our knowledge, this is the first clinical trial investigating the effect of curcuminoids supplementation in critically ill patient with TBI. The findings of the present study will provide evidence on the efficacy and safety of curcuminoids in these patients. TRIAL REGISTRATION NUMBER: (http://www.irct.ir, identifier: IRCT20180619040151N1), Registration date:18.09.2018.

The Relationship between Serum Concentrations of Pro- and Anti-Inflammatory Cytokines and Nutritional Status in Patients with Traumatic Head Injury in the Intensive Care Unit.

Background and objective: The aim of the present study was to examine the relationship between serum levels of pro-inflammatory cytokines (IL-6, IL-1ß, and TNF-α) and anti-inflammatory cytokines (IL-10) measured once at the baseline with changes in nutritional status of patients with traumatic head injury (THI) assessed at three consecutive times (24 h after admission, day 6 and day 13) during hospital stay in the intensive care unit (ICU). Materials and Methods: Sixty-four patients with THI were recruited for the current study (over 10 months). The nutritional status of the patients was determined within 24 h after admission and on days 6 and 13, using actual body weight, body composition analysis, and anthropometric measurements. The APACHE II score and SOFA score were also assessed within 24 h of admission and on days 6 and 13 of patients staying in the ICU. Circulatory serum levels of cytokines (IL-6, IL-1ß, TNF-α, and IL-10) were assessed once within 24 h of admission. Results: The current study found a significant reduction in BMI, FBM, LBM, MAUAC, and APM, of THI patients with high serum levels the cytokines, over the course of time from the baseline to day 7 and to day 13 in patients staying in the ICU (p < 0.001). It was also found that patients with low levels of some studied cytokines had significant improvement in their nutritional status and clinical outcomes in term of MAUAC, APM, APACHE II score and SOFA score (p < 0.001 to p < 0.01). Conclusion: THI patients who had high serum levels of studied cytokines were more prone to develop a reduction of nutritional status in terms of BMI, FBM, LBM MAUAC and APM over the course of time from patient admission until day 13 of ICU admission.

Effect of single-dose injection of vitamin D on immune cytokines in ulcerative colitis patients: a randomized placebo-controlled trial.

Ulcerative colitis (UC) is a chronic recurrent inflammation of the colon. It has been proposed that the UC pathogenesis may be related to vitamin D deficiency and/or vitamin D administration in UC patients may have an ameliorating effect on the intestinal inflammation. The aim of this study was to assess the effect of vitamin D on the serum levels of immune cytokines in UC patients. In this double-blind randomized controlled trial, 90 mild-to-moderate UC patients were assigned to get either a single muscular injection of 7.5 mg vitamin D3 or 1 mL normal saline as placebo. Three months later serum levels of IL-4, IL-10, IL-12p70, IFN-γ, and TNF-α were measured. Two group variables were compared using independent t-test and analysis of covariance (ANCOVA). There was a significant increase in vitamin D only in the vitamin D group. Compared to placebo, vitamin D had significant decreasing effects on serum TNF-α, IFN-γ, and IL12p70 levels, but it had no significant effect on serum levels of IL4 and IL10. Vitamin D seems to inhibit Th1 immune responses and have no effect on Th2 responses. The findings of this study support several in vitro studies, which suggest a therapeutic immunomodulatory potential of vitamin D.

Effects of vitamin D supplementation along with endurance physical activity on lipid profile in metabolic syndrome patients: A randomized controlled trial.

BACKGROUND AND OBJECTIVES: This study was conducted to determine the effects of vitamin D supplementation along with endurance physical activity on lipid profile among metabolic syndrome patients. MATERIALS AND METHODS: In a parallel randomized placebo controlled trial, 70 metabolic syndrome patients, were randomly assigned into three groups. Biochemical tests were assessed as baseline and after 12 weeks of intervention. Statistical analysis was performed using SPSS version 20. RESULTS: The mean vitamin D levels was increased significantly in both vitamin D and vitamin D plus physical activity groups (P value < 0.05). No significant change was observed in the placebo group. Additionally, there was a significant decrease in total cholesterol and LDL-C in vitamin D plus physical activity group (P value < 0.05). No significant differences in changes of triglycerides and HDL-C among the three groups (P value > 0.05). While, in vitamin D group a decreased in total cholesterol, HDL-C, LDL-C and increase in triglycerides were observed, but did not reach a statistically significant. CONCLUSION: Daily supplementation of vitamin D for 12 weeks, along with moderate endurance physical activity, significantly increase vitamin D concentration and induce a significant reduction in lipid profile in metabolic syndrome patients.

Nano-curcumin improves glucose indices, lipids, inflammation, and Nesfatin in overweight and obese patients with non-alcoholic fatty liver disease (NAFLD): a double-blind randomized placebo-controlled clinical trial.

BACKGROUND: Since lifestyle changes are main therapies for non-alcoholic fatty liver disease (NAFLD), changing dietary components (nutritional or bioactive) may play a parallel important role. Few studies have assessed the effects of curcumin on NAFLD (mainly antioxidant and anti-inflammatory effects). We aimed to determine the effects of nano-curcumin (NC) on overweight/obese NAFLD patients by assessing glucose, lipids, inflammation, insulin resistance, and liver function indices, especially through nesfatin. METHODS: This double-blind, randomized, placebo-controlled clinical trial was conducted in the Oil Company Central Hospital, Tehran. 84 overweight/obese patients with NAFLD diagnosed using ultrasonography were recruited according to the eligibility criteria (age 25-50 yrs., body mass index [BMI] 25-35 kg/m2). The patients were randomly divided into two equal NC (n = 42) and placebo (n = 42) groups. Interventions were two 40 mg capsules/day after meals for 3 months. Lifestyle changes were advised. A general questionnaire, a 24-h food recall (at the beginning, middle and end), and the short-form international physical activity questionnaire (at the beginning and end) were completed. Also, blood pressure, fatty liver degree, anthropometrics, fasting blood sugar (FBS) and insulin (FBI), glycated hemoglobin (HbA1c), homeostasis model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), tumor necrosis factor-alpha (TNF-α), high sensitive c-reactive protein (hs-CRP), interleukin-6 (IL-6), liver transaminases, and nesfatin were determined at the beginning and end. RESULTS: NC compared with placebo significantly increased HDL, QUICKI, and nesfatin and decreased fatty liver degree, liver transaminases, waist circumference (WC), FBS, FBI, HbA1c, TG, TC, LDL, HOMA-IR, TNF-α, hs-CRP, and IL-6 (P < 0.05). The mean changes in weight, BMI, body composition (BC), and blood pressure were not significant (P > 0.05). After adjustment for confounders, the changes were similar to the unadjusted model. CONCLUSION: NC supplementation in overweight/obese NAFLD patients improved glucose indices, lipids, inflammation, WC, nesfatin, liver transaminases, and fatty liver degree. Accordingly, the proposed mechanism for ameliorating NAFLD with NC was approved by the increased serum nesfatin and likely consequent improvements in inflammation, lipids, and glucose profile. Further trials of nano-curcumin's effects are suggested. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT2016071915536N3. Registered 2016-08-02.

Vitamin D Decreases Beck Depression Inventory Score in Patients with Mild to Moderate Ulcerative Colitis: A Double-Blind Randomized Placebo-Controlled Trial.

The prevalence of depression in inflammatory bowel disease (IBD) is significantly more than in controls. Some studies assessed the link between vitamin D and depression. The aim of this study was to assess the effect of vitamin D on Beck Depression Inventory (BDI) score in ulcerative colitis (UC) patients. In this double-blind randomized controlled trial, 90 mild to moderate UC patients were assigned to receive a single injection of 300,000 IU vitamin D3 or 1 ml normal saline as placebo. At baseline and 3 months later, measurements of BDI score and serum 25-OH-vitamin D3 were done. Data were compared by independent sample t test, Mann-Whitney U test, and analysis of covariance (ANCOVA). Baseline BDI scores were not statistically different between the two groups (p = .4); scores decreased in the vitamin D group after the intervention (p = .023). Further subgroup analysis regarding baseline serum vitamin D levels and adjusted for baseline BDIs revealed lowering effect of vitamin D on BDI scores only in subgroup with baseline serum vitamin D levels equal to or higher than 30 ng/ml (p < .001). In this study, there was a statistically significant reduction in BDI score in mild to moderate UC patients 3 months after 300,000 IU vitamin D3 injection. Subgroup analysis showed that patients with sufficient baseline vitamin D may benefit from supplementation more than vitamin D-deficient patients, which indicates that higher serum vitamin D levels may be needed for its antidepressant effect.

The effect of a garlic supplement on the pro-inflammatory adipocytokines, resistin and tumor necrosis factor-alpha, and on pain severity, in overweight or obese women with knee osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a prevalent degenerative joint disease, which is associated with chronic and disabling pain. The adipocytokines, resistin and tumor necrosis factor-alpha (TNF-α), might play a role in OA pathogenesis and outcomes. PURPOSE: The aim of this study was, therefore, to assess the anti-inflammatory and analgesic effects of a garlic supplement on serum resistin and TNF-α concentrations and on pain severity in overweight or obese women with knee OA. STUDY DESIGN: Randomized, double-blind, placebo-controlled, parallel-design trial. METHODS: In this study, 80 post-menopausal overweight or obese women (25 ≤ BMI ≤ 40 kg/m2, age 50-75 years) with mild to moderate knee OA were enrolled. Patients were randomly divided into two groups to receive twice-daily either garlic tablets (total: 1000 mg) or placebo for 12 weeks. The primary outcome measures were fasting serum concentrations of resistin and TNF-α, and pain severity (assessed using 0-10 point visual analogue scale (VAS)). RESULTS: At week 12, resistin concentrations were significantly decreased in the garlic group (6.41 ±â€¯2.40 to 5.56 ±â€¯2.16 ng/ml; P = 0.008). Serum TNF-α levels did not change significantly within or between the two groups. Pain scores were significantly reduced in the garlic (6.8 ±â€¯2 to 5.3 ±â€¯2.3; P = 0.002), but not in the placebo (6.7 ±â€¯2.4 to 6.2 ±â€¯2.5; P = 0.674), group. Pain scores were also significantly lower in the garlic, compared with the placebo, group following supplementation (5.3 ±â€¯2.3 vs. 6.2 ±â€¯2.5; P = 0.043). CONCLUSIONS: The findings suggest that garlic supplementation for 12 weeks might reduce pain severity in overweight or obese women with knee OA, which may, at least in part, be mediated via a reduction in the pro-inflammatory adipocytokine, resistin.