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The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and oxidative stress (OS) in patients diagnosed with migraine is unknown and remains to be examined. Hence, we conducted a parallel-group, randomized controlled trial to investigate this issue.Of the 102 women who met all the inclusion criteria, 51 individuals were randomized to the DASH diet group and 51 to the usual dietary advice group to receive allocated intervention for three months. In order to assess the compliance of participants to the DASH diet, dietary records, and serum vitamin C levels were examined. Parameters of OS status (e.g. nitric oxide (NO), total antioxidant capacity (TAC), total oxidative status (TOS), malondialdehyde (MDA), and oxidative stress index (OSI)) and clinical indices of migraine (e.g. migraine index (MI), headache dairy result (HDR), and migraine headache index score (MHIS)) were assessed at the beginning and the end of the study.There was a significant reduction in NO (-5.75 vs. + 4.18,This type of dietary approach can be considered as a complementary treatment for migraine patients, also further investigations are needed to replicate our findings.

The objective of this study was to determine the effects of Nigella sativa oil extract on cardiometabolic risk factors in people with type 2 diabetes (T2D). A randomized, controlled, clinical trial was conducted on 43 patients with T2D (23 women and 20 men; aged 53.5�±�7.4�years). The intervention group (N =�23) received two 500-mg per day soft gel capsules containing Nigella sativa oil extract and the control group (N =�20) received two identical placebo soft gel capsules containing sunflower oil per day for the same period, 8�weeks. Pre- and post-intervention cardiometabolic risk factors were measured. Compared with the placebo, the N. sativa oil significantly decreased FBS (p =�.03(, HbA1c (p =�.001), total cholesterol (p =�.04), TG (p =�.003), LDL-c (p =�.001), BMI (p \textless�.001), waist circumference (p \textless�.001), SBP (p =�.001), and DBP (p =�.002). HOMA-IR (p =�.51) and HDL-c (p =�.91) did not change significantly following Nigella sativa supplementation. Nigella sativa oil exerted beneficial effects on glycemic control, serum lipid profile, blood pressure, and body weight among people with T2D. Further long-term trials in the future may help confirm the current therapeutic benefits of Nigella sativa in T2D.

Background and Aims: This study was designed to make a systematic review and meta-analysis on randomized controlled trials (RCTs) assessing the effect of cinnamon on blood pressure (BP). Methods: A systematic computerized literature search of PubMed, Scopus, Web of Science, Cochrane Library and Google Scholar databases were conducted up to August 2019. All RCTs using cinnamon supplements in adults were included in this systematic review and meta-analysis. Results: Out of 927 records, 8 trials that enrolled 582 participants were included. The pooled effect size showed that SBP did not change following cinnamon supplementation. (WMD: -0.61mmHg; 95% CI: -1.36, 0.14, P= 0.111). Also cinnamon supplementation in long-duration (≥ 8weeks) had a significant effect on SBP (WMD: -1.25 mmHg; 95% CI: -2.22, -0.28, P= 0.012). Pooled analysis showed that cinnamon had a significant effect on DBP (WMD: -0.93mmHg, 95% CI: -1.55 to -0.32, P= 0.003). In addition, results from both duration subsets and high dose (>1500 mg/day) of cinnamon supplementation were significant. Conclusion: Our findings revealed that cinnamon supplementation has favorable effects on DBP although results about SBP were not the same. Nonetheless, further studies are required.

The aim of the study was to compare the effects of a lacto-ovo-vegetarian diet (LOV-D) vs. a standard weight-loss diet (SWL-D) on obese/overweight adults with NAFLD. Present randomised clinical trial recruited 75 overweight/obese adults with NAFLD, who were randomly assigned into LOV-D and SWL-D groups for 3 months. The LOV-D was designed based on eliminating meat, poultry, and fish; while including dairy products and eggs. The SWL-D was planned according to the standard food pyramid, which was free in all sources of food. Adherence to LOV-D significantly outperformed SWL-D in reducing levels of alanine aminotransferase (ALT), body weight, waist circumference, BMI, fasting blood sugar, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), triacylglycerol (TG), cholesterol, low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP). Furthermore, ultrasonography revealed a higher alleviation in NAFLD grade among LOV-D, compared with SWL-D. This study suggests that adherence to LOV-D for 3 months has beneficial effects on NAFLD improvement, anthropometric measures, glycaemic-related markers, and lipid profiles.

The present meta-analysis aimed to determine the effectiveness of L-arginine supplementation in improving biomarkers of glycemic control in adults. Electronic databases including PubMed, ISI Web of Science, Scopus, and the Cochrane Collaboration Library were searched up to January 2020. The meta-analysis of twelve randomised clinical trials indicated that L-arginine had no significant effect on serum fasting blood sugar (FBS) (weighted mean difference [WMD]: -3.38 mg/dl, 95% CI: -6.79 to 0.04, p = .53), serum insulin (WMD: -0.12 Hedges' g 95% CI: -0.33 to 0.09, p = .27), glycated haemoglobin A1c (HbA1c; WMD: -0.04%, 95% CI: -0.25 to 0.17, p = .71), and homeostasis model assessment for insulin resistance (WMD: -0.48, 95% CI: -1.15 to 0.19, p = .15). Although several animal studies have proposed that L-arginine supplementation might improve blood glucose control, the present study could not confirm this benefit in humans.

Purpose A number of studies have examined the association between vitamin D and dry eye disease in different populations, but findings are inconclusive. Herein, available observational studies were systematically reviewed to elucidate the overall relationship between vitamin D and dry eye disease among adult population. Methods PubMed, Scopus, Google scholar and ISI web of science databases were searched until January 2020 for studies assessing the association between vitamin D and dry eye disease. The Newcastle-Ottawa Quality Assessment Scale was used to examine the quality of each study. Results A total of 14 studies out of 252 met the inclusion criteria and were included in this systematic review and meta-analysis. Serum 25(OH) D3 was lower in dry eye disease subjects compared to healthy ones (WMD −5.93; 95 % CI, −7.47 to −4.40; P Conclusion It was found that serum vitamin D had a significantly lower level in dry eye disease patients, and correlated with ocular surface disease index but no other dry eye disease parameter. The findings add to the existing literature supporting the concept that nutrition especially vitamin D plays an important role in human eye health. Prospective studies are needed to confirm this relationship

Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.

Background: There is a well-documented cross-talk between the gut and brain. Evidence is accumulating to suggest beneficial effects of psychobiotics [prebiotics, probiotics or synbiotics] on psychological distress in disease states. However, their role in healthy status remains relatively unclear. Objectives: The present study was aimed to clarify if psychobiotics could influence behavioral responses and physiological stress in healthy rats. Methods: In the present experiment, 28 male Wistar rats were divided into four groups (healthy rats treated by Lactobacillus plantarum (L.plantarum), inulin and their combination (synbiotic) and control group). Then, psychobiotics were administered to the intervention groups for 8 weeks. Behavioral tests (Morris water maze, Elevated plus maze, and Forced swimming test) were performed at the endpoint. Then, serum and brain levels of superoxide dismutase, malondialdehyde, glutathione peroxidase, total antioxidant capacity, brain-derived neurotrophic factor (BDNF), and serotonin were measured. Results: Our finding indicated that unlike inulin, the administration of L.plantarum and synbiotic could ameliorate depression and anxiety-like behavior and cognitive performance (P

Few studies have assessed the association between sodium (Na) and potassium (K) and migraine headaches. In this study, we aimed to examine the relationship between 24-hour urine Na and K intakes and clinical findings of migraine in an Iranian sample. In this cross-sectional study, 262 participants, aged 20–50 years, were included with a body mass index (BMI) of 18·5–30 kg/m2 and a diagnosis of migraine. One 24-hour urine sample was collected from each subject to estimate the Na and K intakes. The clinical features of migraine, including frequency, duration, severity, Migraine Headache Index Score (MHIS), and Headache Impact Test (HIT) score, were assessed. Besides, a multiple linear regression analysis was performed, and beta estimates and the corresponding 95% confidence intervals (CIs) were reported. Overall, 224 women and 38 men, with a mean age of 36·10 years and BMI of 25·55 kg/m2 comprised our study population. After controlling for potential confounders, the 24-hour urine Na was positively associated with a longer headache duration (β = 0·29; 95% CI: 0·06, 0·53) in the group with the highest urine Na levels as compared to the group with the lowest levels. After adjustments for potential confounders, an increase of 13·05 in the MHIS was observed when the 24-hour urine Na level increased from the first to the third tertile (β = 13·05; 95% CI: 1·70, 24·41). Our findings suggested that a higher 24-hour urine Na level was positively associated with a longer duration of migraine headaches and a higher MHIS.

Neuroprotective effects of curcumin have been shown in previous studies. This updated systematic review of clinical trials aimed to investigate the effect of curcumin on neurological disorders. Databases including PubMed, Scopus, Web of Science, and Google Scholar were systematically searched to identify clinical trials investigating the effects of curcumin/turmeric supplements alone, or in combination with other ingredients, on neurological diseases. Nineteen studies comprising 1,130 patients met the inclusion criteria. Generally, intervention and study outcomes were heterogeneous. In most of the studies, curcumin had a favorable effect on oxidative stress and inflammation. However, with the exception of AD, curcumin supplementation either alone, or in combination with other ingredients, had beneficial effects on clinical outcomes for the other aforementioned neurodegenerative diseases. For example, the frequency, severity, and duration of migraine attacks, scores on the revised ALS functional rating scale, and the occurrence of motor complications in PD were all significantly improved with curcumin supplementation either alone or in combination with other ingredients. However, in three studies, several adverse side effects (mostly gastrointestinal in nature) were reported. Curcumin supplementation may have favorable effects on inflammatory status and clinical outcomes of patients with neurological disease, although the results were not consistent.

Background The contribution of vitamin D to thyroid disorders has received paramount attention; however, results are mixed. Hence, we designed a systematic review and meta-analysis to obtain a definitive conclusion. Methods The search included PubMed, ISI Web of Science, Scopus, and Google Scholar databases up to March 2021 to collect available papers reporting the relationship between serum levels of vitamin D and thyroid disorders. The pooled effect was reported as weighted mean difference (WMD) and 95% confidence interval (CI). Results Out of 6123 datasets, 42 were eligible to get into this systematic review and meta-analysis. Serum vitamin D was markedly lower in autoimmune thyroid diseases (AITD) (WMD − 3.1 ng/dl; 95% CI, − 5.57 to − 0.66; P = 0.013; I2 = 99.9%), Hashimoto’s thyroiditis (HT) (WMD − 6.05 ng/dl; 95% CI, − 8.35 to − 3.75; P 2 = 91.0%) and hypothyroidism patients (WMD − 13.43 ng/dl; 95% CI, − 26.04 to − 0.81; P = 0.03; I2 = 99.5%), but not in subjects with Graves’ disease (GD) (WMD − 4.14 ng/dl; 95% CI, − 8.46 to 0.17; P = 0.06; I2 = 97.5%). Conclusions Our findings suggested lower vitamin D levels in patients with hypothyroidism, AITD, and HT compared to healthy subjects. However, the link between serum vitamin D and GD was only significant among subjects ≥40 years old.

Background. Statins reportedly have anti-inflammatory effects aside from their lipid-lowering impact. We investigated the effects of statin therapy on the level of C-reactive protein (CRP) or highly sensitive CRP (hs-CRP), a liver-derived marker of systemic inflammation, among stroke patients. Methods. An online search was performed in Scopus, PubMed/MEDLINE, ISI Web of Science, and Google Scholar up to November 2020 to recognize clinical trials investigating the effects of statins on the CRP level in stroke patients. Results. Overall, nine studies (11 treatment arms) with 1659 participants met the inclusion criteria. Six out of 9 studies (8 out of 11 arms) were categorized as studies with a high-quality methodological approach using the Cochrane Collaboration’s tool. Data from 5 treatment arms indicated a significant decrease in CRP concentration, and in one treatment arm, CRP concentration did not suggest any considerable alteration following statin therapy. Moreover, two treatment arms showed a significant reduction in hs-CRP concentration and three treatment arms revealed no significant alteration in hs-CRP concentration following statin therapy. Generally, results were heterogeneous and independent of the type of statin, statin dose, treatment duration, and changes in plasma low-density lipoprotein cholesterol concentration. Conclusion. The results suggest that statin therapy could reduce and, therefore, could be considered in these patients as potential anti-inflammatory agents.

Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). Trial design This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. Participants The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o’clock. Main outcomes The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). Follow up All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days’ mortality in the ICU, 4 weeks follow up). Randomisation Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. Blinding (masking) This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. Numbers to be randomised (sample size) The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. Trial Status The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. Trial registration This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of “Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study”. IRCT registration number is IRCT20121216011763N52. The registration date was May 13, 2021. Full Protocol The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Purpose A number of studies have examined the association between vitamin D, fertility and semen quality, however, findings have been inconclusive. Herein, we systematically reviewed available observational studies to elucidate the overall relationship between vitamin D, fertility and semen quality in adult population. Methods PubMed, Cochrane's Library, Science Direct, Scopus, Google Scholar and ISI Web of Science databases were searched until December 2018 for all available studies evaluating the association between vitamin D, fertility and semen quality. The Newcastle-Ottawa Quality Assessment Scale was used to examine the quality of each study. Results A total of 18 studies out of 1843 met our inclusion criteria and were included in our systematic review and meta-analysis. Serum 25(OH)D3 was significantly higher in fertile subjects compared to infertile ones (WMD -0.63; 95% CI, −1.06 to −0.21; P = 0.003). Furthermore, there was a significant association between serum 25(OH)D, sperm motility (WMD -5.84; 95% CI, −10.29 to −1.39; P = 0.01) and sperm progressive motility (WMD -5.24; 95% CI, −8.71 to −1.76; P = 0.003). Conclusion Our findings add to the existing literature supporting the concept that nutrition, especially vitamin D, plays an important role in men's sexual health. It should be noted that because of significant heterogeneity among the included studies, caution is warranted when interpreting the results. Further well-designed prospective cohort studies and clinical trials are needed for better understanding of the relationship between vitamin D and fertility and its components.

Background & aims Existing evidence on the possible effects of pro-/synbiotics on overweight or obese children and adolescents has not been fully established. Therefore, the present review was undertaken to evaluate the overall effects of pro-/synbiotics supplementation on anthropometric indices and metabolic indices in overweight or obese children and adolescents. Methods A systematic computerized literature search of PubMed, Scopus, ISI Web of science and Google Scholar databases was conducted up to November 2018. All RCTs using pro-/synbiotics supplements in overweight or obese children and adolescents included in this systematic review and meta-analysis. Results Overall 9 randomized trials including 410 subjects were identified for the present meta-analysis. Pooled analysis did not illustrate any significant changes in BMI z-score, waist circumference, weight, body fat, fasting blood sugar and lipid profiles (triglyceride, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) after supplementation with pro-/synbiotics for 4–16 weeks. However, subgroup analysis by intervention type revealed a significant reduction of BMI z-score in synbiotic subgroups. Conclusion Based on our findings, modulation of gut microbiota composition through pro-/ synbiotic supplements did not have favorable effects to manage overweight or obese children and adolescents. Further large-scale studies are warranted to confirm present findings.

IntroductionHomoeostasis model assessment (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI) are used to evaluate insulin resistance. The aim of this study was to investigate the association between quantitative insulin sensitivity indices and anthropometric and cardiometabolic indicators in adolescents.Material and methodsThis descriptive-analytic cross-sectional study was conducted on 80 adolescents aged 12 to 13 years in Isfahan, Iran. Anthropometric, cardiometabolic and QUICKI and HOMA-IR indicators were measured. In the results analysis, Pearson correlation coefficient and regression analysis were used.ResultsThere was a significant positive correlation between most of the anthropometric indicators and the HOMA-IR index and a significant negative correlation with QUICKI (all p < 0.0001). Moreover, serum triglyceride level had a significant negative correlation with QUICKI index (R = –0.33, p = 0.002) and systolic blood pressure (R = 0.44, p < 0.0001), and triglyceride level (R = 0.66, p < 0.0001) had a significant positive correlation with HOMA index. The results of these two indices were highly correlated in most of the anthropometric and biochemical indices, except for the waist circumference to the neck circumference ratio and systolic blood pressure, which had a significant positive association with HOMA-IR, but did not show a significant association with QUICKI index.ConclusionsA significant correlation between anthropometric and cardiometabolic indicators with insulin resistance indices (HOMA-IR and QUICKI) was found. Moreover, the results of these two indices were highly correlated in most of the anthropometric and biochemical indices, except for the waist circumference to the neck circumference ratio and systolic blood pressure.

In diabetic polyneuropathy (DPN) patients, the effect of folic acid and homocysteine has been related to components of nerve conduction velocity (NCV). The objective of this study was to determine the effect of folic acid supplementation on NCV in DPN patients.Patients were randomized to receive either 1 mg of folic acid (n = 40) or placebo (n = 40) for 16 weeks. Blood samples were collected to assess serum folic acid and homocysteine concentrations, and NCV was performed for assessment of diabetic neuropathy.At 16 weeks, in the supplemented group, serum levels of folic acid (p 0.001) increased, homocysteine concentrations decreased (p 0.001), with no change in serum vitamin B12 levels. There was a significant increase in sensory sural amplitude (p 0.001), and components of motor nerves, including amplitude (p = 0.001) and velocity (p 0.001), but decreased onset latency of peroneal (p = 0.019) and tibial (p = 0.011) motor nerves.Our data suggest that supplementation with 1 mg of folic acid for 16 weeks may be useful for enhancing NCV in DPN patients.

Purpose The present study aimed to determine the effects of combined supplementation of Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders marker and migraine symptoms among migraine patients. Methods A total of 56 men and women, between 20–40 years of age with migraine headache, participated in this randomized, double-blind, placebo-controlled, parallel study. The subjects were randomly assigned to receive either 30 mg/day Coenzyme Q10 and 500 mg/day L-carnitine at the same time and/or placebo tablets for 8 weeks. The measurements were completed at the beginning and end of the study. The primary outcome was severity of headache attacks. The secondary outcomes included duration, frequency of headache attacks, the headache diary results (HDR), and serum levels of lactate. Results A significant reduction was obtained in serum levels of lactate (−2.28 mg/dl, 95% CI: −3.65, −0.90; p = 0.002), severity (−3.03, 95% CI: −3.65, −2.40; p ≤ 0.001), duration (−7.67, 95% CI: −11.47, −3.90; p ≤ 0.001), frequency (−5.42, 95% CI: −7.31, −3.53; p ≤ 0.001) and HDR (−103.03, 95% CI: −145.76, −60.29; p ≤ 0.001) after 8 weeks. Conclusion This double-blind parallel study provides evidences supporting the beneficial effects of Coenzyme Q10 and L-carnitine supplements on serum levels of lactate and migraine symptoms. Trial registration IRCT20121216011763N21.

Literature suggests a relationship between gut microbiome and migraine headache pathogenesis. However, the effect of manipulating gut microbiome on migraine remains unclear. This study aimed to investigate the effect of synbiotics on migraine characteristics and inflammatory markers in women with migraines. Sixty-nine participants completed a randomized double-blind controlled trial, receiving synbiotic (109 CFU of 12 types of probiotics + fructooligosaccharides prebiotic) or placebo supplementation, twice per day for 12 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, number of painkillers consumed, gastrointestinal problems, serum High sensitive C-Reactive Protein (Hs-CRP) (a marker of inflammation) and zonulin (a marker of gut permeability) levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis. Synbiotic supplementation compare to the placebo resulted in a significant reduction in the mean frequency of migraine attacks (−1.02 vs −0.30, respectively, P = 0.011), percentage change of the number of painkillers used (−7.5% vs 27.5%, respectively, P = 0.008) and gastrointestinal problems (−35% vs −2.5%, respectively, P = 0.005), zonulin level (−4.12 vs 0.85 ng/ml, respectively, P = 0.034), and Hs-CRP level (−0.43 vs −0.09 mg/l, respectively, P = 0.022). Reduction in the migraine severity and duration did not reach a statistically significant level. Synbiotic supplementation may be considered as a complementary treatment for women with migraines to improve migraine characteristics and markers of inflammation and gut permeability and reduce the burden of disease.

AIM Migraine is a common neurovascular disorder, which is associated with severe to moderate disabling headaches. Oxidative stress and inflammation might play a role in migraine pathogenesis and the mood disorders. Considering the antioxidant and anti-inflammatory properties of alpha-lipoic acid (ALA), this study was designed to investigate its effect on oxidative, inflammatory, and mood conditions in women with episodic migraine. METHODS In total, 92 women with episodic migraine participated in the study. The patients were randomly divided into two groups, receiving a 300-mg capsule of ALA or placebo twice daily for 3 months. To assess the oxidative and inflammatory status, the serum levels of total antioxidant capacity (TAC), total oxidant status (TOS), glutathione (GSH), malondialdehyde (MDA), oxidative stress index (OSI), and C-reactive protein (CRP) were determined at the beginning and at the end of the intervention. A depression, anxiety, stress scale (DASS-21-items) questionnaire was used to evaluate mood status. RESULTS Finally, 79 patients reached the final analysis stage. At the end of the intervention, a significant decrease in the serum levels of MDA (means difference [MD]: -0.83, 95% confidence intervals (CI): -1.04, -0.62 nmol/mL vs MD: -0.32, CI: -0.48, -0.15 nmol/mL; P

Type 2 diabetes mellitus (T2DM) is a chronic metabolic condition, which carries considerable morbidity and mortality. There is growing evidence that curcumin could modulate glucose homeostasis and improve vascular risk in patients with T2DM. The aim of this systematic review was to study the effect of curcumin on glycemic indices in patients with diabetes. A comprehensive search was conducted in PubMed, Scopus, Embase, and Google Scholar up to March 5, 2020, to identify randomized control trials investigating the effect of curcumin supplementation on glycemic indices including fasting blood glucose (FBS), hemoglobin A1c (HbA1C), and the homeostatic model assessment for insulin resistance (HOMA-IR). Eleven articles comprising 1131 individuals with T2DM were included in the study. Treatment with curcumin significantly reduced the level of FBS and HbA1c in 8 and 7 studies, respectively. HOMA-IR was evaluated in five studies, and this was reduced significantly by curcumin supplementation in three of those studies. Patients who took curcumin supplementation over longer periods (≥12 weeks) showed a significant reduction in glycemic indices. The current systematic review showed that curcumin can improve glycemic control in patients with T2DM. However, further studies are required to determine the optimum conditions for these effects of curcumin, particularly regarding readouts of insulin resistance.

Prostate cancer is one of the significant causes of morbidity and mortality worldwide. Benign prostatic hyperplasia is another condition of the prostate which, like prostate cancer, is more common among ageing men and is linked to inflammation. In this study, a systematic review was undertaken to estimate the effect of turmeric or curcumin supplementation on prostate diseases. A comprehensive search was conducted in PubMed, Scopus, ISI Web of Science and Google Scholar up to 15 April 2020 to identify clinical trials assessing the effects of curcumin/turmeric alone or in combination with other herbs on prostate diseases. This led to the identification of 11 records comprising 745 patients who met the eligibility criteria. Eight studies were conducted on patients with prostate cancer, and three were on other diseases of the prostate. Although outcomes across the studies were heterogeneous, in some studies curcumin/turmeric supplementation had some favourable effects. This included beneficial effects on the levels of prostate-specific antigen (PSA) (2/6 studies), quality of life (1/2 studies), as well as on oxidative stress markers, feelings of incomplete bladder emptying, urination frequency, intermittency, urgency, weak stream, straining and nocturia. Curcumin/turmeric supplementation had no significant adverse effects among patients. This study demonstrated that turmeric or curcumin supplementation might have beneficial effects on some parameters related to prostate diseases, but it should be noted that some studies showed no effect. Therefore, further studies using curcumin-related compounds, particularly in highly bioavailable forms, are needed to assess the impact of curcumin on prostate conditions.

Cardiovascular disease (CVD) is a major cause of death worldwide. Lipid abnormalities are one of the major risk factors for CVD. Curcumin is a natural polyphenol with lipid-lowering properties. Therefore, we carried out a systematic review to summarize the randomized controlled trials (RCTs) investigating the effect of curcumin on lipid profile in patients at risk of CVD. A comprehensive systematic search was conducted in PubMed, Scopus, Web of Science, and Google Scholar up to March 1, 2020, to identify controlled clinical trials assessing the effects of curcumin on lipid profile in patients at risk of CVD. From 1051 initially identified studies, 22 met the eligibility criteria. Curcumin supplementation significantly reduced at least one of the lipid profile indices (triglycerides, total cholesterol, low-density lipoprotein-cholesterol, and high-density lipoprotein-cholesterol) in 15 studies and improved more than one index in five studies. However, curcumin had no effect on any of lipid profile indices in seven studies. Overall, studies using a bioavailable formulation of curcumin had a better impact on the lipid profile. The findings of this systematic review showed that curcumin supplementation significantly reduced at least one of the lipid profile indices in more than two-thirds of the included studies. Curcumin might be used as an accessible, inexpensive, and safe agent to reduce risk of CVD. More randomized, clinical controlled trials are needed to verify these results.

Osteoarthritis is characterized by degeneration of joint structure over time, resulting in limitation of joint mobility. There is growing evidence that curcumin has anti-inflammatory properties and could be a potential therapeutic option for chronic inflammatory diseases. Hence, curcumin could potentially have a positive impact on osteoarthritis symptoms. This systematic review aimed to estimate the effects of curcumin on osteoarthritis. We systematically searched PubMed, ISI, Scopus, and Google Scholar up to March 4, 2020 to identify randomized controlled trials that evaluated the effects of consumption of all types of curcumin compounds in the treatment of osteoarthritis, especially in patients with knee osteoarthritis. Seventeen trials were identified. The duration of the included studies varied from 4 weeks to 8 months. Across all trials, 13 studies involved screening using Western Ontario and McMaster Universities (WOMAC) scores and 11 studies used visual analog scales (VAS) for recording pain from baseline to post-intervention. There was a significant improvement in VAS and overall WOMAC scores with oral administration of various types of curcumin formulations with no severe adverse effects. In conclusion, different types of curcumin compounds may be beneficial as an alternative or complementary agent for the management of osteoarthritis. Moreover, certain curcumin compounds with higher bioavailability tended to show more positive effects.

Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints, which is prevalent in about 0.5–1.0% of the world population. Newer therapies for RA have only minimal efficacy in some cases and some adverse effects. Curcumin with anti-antioxidant, anti-inflammatory, and immunomodulatory properties might have beneficial effects on RA. We have carried out a systematic review with the main aim of estimating the effect of curcumin supplementation on RA. A systematic search of the medical databases, PubMed, Scopus, ISI, and Google Scholar was performed up to March 21, 2020 to identify clinical trials assessing the effect of turmeric or curcumin on RA. Six studies, comprising 259 patients with RA of 6–12 weeks duration, were included. Disease activity was assessed using 28 joints (DAS-28), visual analog scale (VAS), and American College of Rheumatology (ACR-20) scores. Treatment with curcumin significantly reduced DAS-28 scores in four out of five studies and VAS scores for pain in all three studies and significantly increased ACR-20 scores in all three studies in which it was measured. Erythrocyte sedimentation rate (ESR) and circulating C-reactive protein (CRP) were assessed in six and five studies, respectively, out of which four studies reported significant reductions in these parameters in response to curcumin treatment. Rheumatoid factor (RF) was significantly reduced after consumption of curcumin in all three relevant studies. None of the studies reported serious adverse effects with curcumin consumption. The present systematic review suggests that curcumin could be used as a safe agent to treat RA. Thus, further validation is justified.

Background: Curcumin is an active molecule present in turmeric and is the main therapeutic compound. There is growing evidence that curcumin could affect various anthropometric indices. We performed a systematic review to evaluate the efficacy of curcumin supplementation on anthropometric indices in obese and overweight individuals.

Chronic kidney disease (CKD) is one of the significant causes of morbidity and mortality worldwide, which could develop and progress to end-stage renal disease. Increased inflammation and reduced antioxidant capacity commonly occur in CKD and hemodialysis patients. Curcumin is a natural bioactive compound with antioxidant and anti-inflammatory properties. This systematic review was undertaken with the main aim of assessing the effects of curcumin/turmeric supplementation on renal diseases based on clinical trials. A comprehensive search was performed in PubMed/MEDLINE, Scopus, ISI Web of Science, and Google Scholar from inception up to April 6, 2020 to identify clinical trials assessing the effects of curcumin or turmeric alone, or in combination with other herbs or nutrients on renal diseases. Twelve studies met the eligibility criteria. These randomized controlled trials (RCTs) comprised 631 patients with either chronic kidney diseases (CKD), hemodialysis, diabetic proteinuria and nephropathy, and lupus nephritis. Curcumin/turmeric supplementation had favorable effects on renal diseases, particularly in terms of inflammation and oxidative stress. However, with the exception for proteinuria, their impact on clinical parameters, such as blood urea nitrogen, creatinine, glomerular filtration rate (GFR), and serum albumin, was weak and not significant. No serious adverse effects were reported following curcumin/turmeric supplementation. Within the limitations of this review, it can be concluded that curcumin/turmeric supplementation might have some beneficial effects on inflammatory and oxidative stress parameters of patients but no considerable positive impact on clinical outcomes of kidney diseases, apart from proteinuria.

BACKGROUND Hyperhomocysteinaemia is known to interfere with neurological functions; however, there is a controversy regarding the relationship between homocysteine and depression. MATERIALS AND METHODS Science Direct, MEDLINE and ISI Web of Science were searched to find relevant articles, published up to August 2020. Studies were included if they compared homocysteine levels in healthy subjects with subjects with depression. Also, articles that reported the association between hyperhomocysteinaemia and risk of depression were included. Odds ratios of depression and means of homocysteine were used to ascertain the overall effect size. RESULTS Homocysteine level was higher in subjects with depression in comparison with healthy controls (weight mean difference = 2.53 µmol/L, 95% confidence interval: 1.77, 3.30), and the depression diagnostic tool was a source of heterogeneity. Homocysteine level was significantly higher in subjects with depression in studies that used Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV), Geriatric Depression Scale (GDS), Zung Self-Rating Depression Scale (ZDRS) and Beck Depression Index II (BDI-II) as depression diagnostic tools. Also, participants with hyperhomocysteinaemia had a higher chance of depression (Pooled risk = 1.34, 95% confidence interval: 1.19, 1.52), where the depression diagnostic tool was a source of heterogeneity. In contrast to ZDRS and Patient Health Questionnaire (PHQ) subgroups, hyperhomocysteinaemia yielded a significantly higher risk of depression in DSM-IV, GDS and 'other' subgroups. CONCLUSION Homocysteinemia level is higher in individuals with depression. However, the depression diagnostic tool used is instrumental in influencing their association, and thus, future studies should focus on the tools for depression assessment.

Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529. The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Objectives This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). Trial design This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. Participants Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. Intervention and comparator Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Main outcomes The main outcomes are changes in the coronavirus disease’s clinical symptoms including duration and severity from baseline to the end of 2 weeks. Randomization Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial’s pharmacist with the use of random-number tables. Blinding (masking) The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. Numbers to be randomized (sample size) The calculated total sample size is 80 patients, with 40 patients in each group. Trial status The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. Trial registration The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1. Date of trial registration: 20 October 2020, retrospectively registered. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Background Observational studies have shown a link between zinc deficiency and migraine headaches. We aimed to examine the effect of zinc supplementation on the characteristics of migraine attacks in patients with migraine. Methods This randomized clinical trial was conducted on 80 patients with migraine. Patients were randomly assigned to receive either zinc sulfate (220 mg/d zinc sulfate) or placebo (lactose) for 8 weeks. Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results) were assessed at baseline and end of the trial. Results Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (− 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (− 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients. However, the observed reduction for headache severity became statistically non-significant when the analysis was adjusted for potential confounders and baseline values of headache severity. Other characteristics of migraine attacks including the duration of attacks and headache daily results were not altered following zinc supplementation either before or after controlling for covariates. Conclusion Zinc supplementation had a beneficial effect on the frequency of migraine attacks in migraine patients. Additional well-designed clinical trials with a long period of intervention and different dosages of zinc are required. Trial registration code IRCT20121216011763N23 at www.irct.ir.

Pneumonia is a major cause of morbidity and mortality worldwide and causes a significant burden on the healthcare systems. Curcumin is a natural phytochemical with anti-inflammatory and anti-neoplastic characteristics. The aim of this study was to conduct a systematic review of published studies on the effect of curcumin on preclinical models of pneumonia. A comprehensive search was conducted in PubMed/Medline, Scopus, Web of Science and Google Scholar from inception up to March 1, 2020 to recognize experimental or clinical trials assessing the effects of curcumin on pneumonia. We identified 17 primary citations that evaluated the effects of curcumin on pneumonia. Ten (58.8%) studies evaluated the effect of curcumin on mouse models of pneumonia, generated by intranasal inoculation of viruses or bacteria. Seven (41.2%) studies evaluated the inhibitory effects of curcumin on the pneumonia-inducing bacteria. Our results demonstrated that curcumin ameliorated the pneumonia-induced lung injury, mainly through a reduction of the activity and infiltration of neutrophils and the inhibition of inflammatory response in mouse models. Curcumin ameliorates the severity of pneumonia through a reduction in neutrophil infiltration and by amelioration of the exaggerated immune response in preclinical pneumonia models.

Background Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease and refers to the accumulation of triglycerides in hepatocytes. Recent studies have showed that resveratrol (antioxidant of grape) can be effective in the treatment of NAFLD through its inhibitory effect on lipid accumulation. Method We systematically searched databases including: ISI web of science, Scopus, PubMed and Embase by using related keywords. Then, by considering inclusion and exclusion criteria, appropriate articles were selected. All the analyses were conducted in Review Manager (RevMan) Version 5.3. Results Finally, 6 RCTs were included in meta-analysis and systematic review. Our results showed that resveratrol supplementation significantly reduced levels of TNF-alpha (SMD = −0.46; 95% CI (−0.78, 0.14); P = 0.005) and hs-CRP (SMD = −0.53; 95% CI (−1.01, −0.05); P = 0.030), but for other markers (BW, BMI, WC, HC, WHR, SBP, DBP, ALT, AST, GGT, ALP, bilirubin, TC, TG, HDL, LDL, LDL to HDL ratio, apo-A1, apo-B, insulin, HOMA-IR, glucose, creatinine and IL-6), no significant change was observed. Conclusion Overall, the results of the present study show that resveratrol supplementation does not affect the management of NAFLD although it can improve some inflammatory markers.

The aim of this study was to determine the effects of Mg supplementation on anthropometric indices consisting of body weight, waist circumference (WC), BMI and body fat percentage. In this systematic review and dose–response meta-analysis, we searched PubMed, Cochrane Library, Scopus, Web of Science and Google Scholar from databases inception up to February 2020 for relevant randomised controlled trials. Quality of evidence was evaluated using the Cochrane Collaboration Tool. All the outcomes of this meta-analysis were pooled using the random effect model. Analysis of dose–response for Mg dosage was carried out using a fractional polynomial model. The systematic review and meta-analysis include twenty-eight randomised clinical trials, comprising 2013 participants. There were no significant changes in anthropometric indices after Mg supplementation in the overall analysis. However, subgroup analysis revealed that Mg supplementation decreases WC in subjects with BMI > 30 kg/m2 (obese) (twelve trials, n 997 participants; weighted mean difference = –2·09 cm, 95 % CI –4·12, –0·07, P = 0·040; I2 = 0 %). Dose–response analysis revealed a non-significant non-linear effect of supplementation dosage on anthropometric indices. The results suggest that Mg supplementation is associated with lower WC only in obese subjects. However, more high-quality studies are needed to clarify the nature of this association.

Objective We identified and quantified the results of randomized clinical trials by examining the effect of barberry supplementation on blood pressure. Methods We conducted a comprehensive search in the medical bibliographic database up to May 2020 on randomized clinical trials investigating the effect of barberry supplementation on adult blood pressure. Intensive literature searches and data extraction according to a prefixed scheme was performed independently by two investigators. Results Through 5 randomized clinical trial studies, 350 subjects with 175 cases for the intervention group and 175 cases for control group were included in our study. The intervention period ranged from 4 to 12 weeks. In general, barberry supplementation did not have a significant effect on systolic blood pressure (WMD: -4.15 mmHg; 95 % CI: -10.3, 1.99, P = 0.185) and diastolic blood pressure (WMD: -1.22 mmHg; 95 % CI: -6.26, 3.82, P = 0.635). Our study was heterogeneous and subgroup analysis did not eliminate heterogeneity. Conclusion Totally, based on this study, we cannot conclude that barberry supplementation has beneficial effects on blood pressure. Also, all included studies had limitations such as different in geographical situations, Dietary of participants, health conditions, and pharmacological forms of berberis. Therefore, further study in this area is recommended.

BACKGROUND: The available evidence regarding the possible effects of resveratrol on liver function is inconsistent. Therefore, the present meta-analysis was performed to investigate the overall effects of resveratrol supplementation on liver enzymes in adults. METHODS: A systematic and comprehensive search of the online medical databases including PubMed, Scupos, Web of Science and Cochran Library was performed up to February 2020. All RCTs using resveratrol supplements in adults were included in this systematic review and meta-analysis. The overall effect was presented as weighted mean difference (WMD) and 95% confidence interval (CI) in a random-effects meta-analysis model. RESULTS: Finally, 15 randomized trials including 714 participants were selected for the present meta-analysis. Pooled analysis did not show any significant changes in alanine aminotransferase (ALT) (WMD: 0 IU/L, 95% CI: -3.17 to 3.17, p = 0.99; I2 = 74.2%), aspartate aminotransferase (AST) (WMD: -2.40 IU/L, 95% CI: -5.45 to 0.65, p = 0.11; I2 = 82.9%), gamma-glutamyl transferase (GGT) (WMD: -1.26 IU/L, 95% CI: -4.64 to 2.13, p = 0.64; I2 = 23.7%), alkaline phosphatase (ALP) (WMD: 3.80 IU/L, 95% CI: -4.65 to 12.25, p = 0.37; I2 = 29.9%) and bilirubin (WMD: 0.13 IU/L, 95% CI: -0.43 to 0.17, p = 0.39; I2 = 8.9%) after supplementation with resveratrol. CONCLUSION: Overall in our study resveratrol does not effect on liver enzyme levels significantly, but subgroup analysis indicates that these results may be influenced by resveratrol dose, duration of the study and population status, so future high-quality studies are necessary to get definitive results.

Today synbiotics are considered as immunomodulatory agents. The current systematic review and meta-analysis investigated the effect of synbiotics and probiotics on inflammatory and oxidative stress markers in autoimmune disease.The English literature search was performed using PubMed, Scopus, Web of Science, and the Central Cochrane Library through March 2020. Random effects models and generic inverse variance methods were used to synthesize quantitative data by STATAFrom a total of 623 entries identified via searches, ten RCTs (n = 440; 216 as intervention, 224 as controls) were included. An additional eleven studies with same intervention and different markers were also explained systematically. The pooled effect size showed that Interleukin (IL)-6 (WMD = -7.79 pg/ml; 95% CI = -13.81, -1.77, P = 0.011), Tumor Necrosis Factor (TNF)-α (WMD = -1.05 pg/ml; 95% CI = -2.01, -0.10, P = 0.030), high sensitivity C-Reactive Protein (hs-CRP) (SMD = -0.58; 95% CI = -0.79, -0.37, P 0.001), Malondialdehyde (MDA) (SMD = -0.36; 95% CI = -0.68, -0.04; P = 0.026), Homeostasis Model of Assessment-estimated Insulin Resistance (HOMA-IR) (WMD = -0.71; 95% CI = -1.05, -0.37, P 0.001), and beta cell function (HOMA-β) (WMD = -15.18; 95% CI = -22.08, -8.28, P 0.001) changed following probiotics (or synbiotics) supplementation. Also supplementation with doses more than 2 billion CFU could reduce IL-10 concentrations (WMD = -1.84; 95% CI = -2.23, 1.87; P 0.001). Glutathione (GSH) and Total Antioxidant Capacity (TAC) levels did not influence by synbiotics and probiotics; insignificancy was remained after subgrouping for participants' age, study duration, and disease duration.Our findings revealed that synbiotics and probiotics supplementation has significant effect on some inflammatory and oxidative stress markers; although, the number of trials was too small to powerful conclusion and further investigations may be needed.

Migraine is the most common type of primary headaches. Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain. Cinnamon has anti-inflammatory and neuroprotective properties. Thus, the aim of this study was to assess the effect of cinnamon on migraine attacks and inflammatory status. Fifty patients with migraine were randomized to receive either cinnamon powder (three capsules/day each containing 600 mg of cinnamon) or three placebo capsules/day each containing 100 mg of corn starch (control group) for 2 months. Serum levels of IL-6, CGRP and NO were measured at baseline and at the end of the study. The frequency, severity and duration of pain attacks were also recorded using questionnaire. Serum concentrations of IL-6 and NO were significantly reduced in the cinnamon group compared with the control group (p < .05). However, serum levels of CGRP remained unchanged in both groups. The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group. Cinnamon supplementation reduced inflammation as well as frequency, severity and duration of headache in patients with migraine. Cinnamon could be regarded as a safe supplement to relieve pain and other complications of migraine.

Background & aims Hypertension is a predisposing factor for cardiovascular disease (CVD). Results of previous clinical trials on the effects of lycopene supplementation on blood pressure are inconsistent. This systematic review and meta-analysis of randomized trials with parallel or cross-over design was conducted to summarize the effects of lycopene supplementation on blood pressure (BP). Methods A systematic search was carried out in PubMed, SCOPUS, EMBASE and ISI Web of Science, without any restrictions on date and language publication to February 2020. Data were pooled using random-effects method and were expressed as weighted mean difference (WMD) and 95% confidence intervals (CI). Results The elementary search consisted of 2564 records. Finally, 10 RCTs were included in the study. The pooled results of 10 studies with 16 effect size sizes including 688 participants (case=438 and control=250) showed that lycopene supplementation significantly decreased systolic blood pressure (SBP) (weighted mean differences (WMD): − 2.63 mmHg; 95% CI: − 5.17, − 0.09; P = 0.042). Greater effects on SBP were observed in subjects with a baseline SBP≥ 130 mmHg, at the lycopene dosages of ≥ 15 mg, duration≥ 8 weeks, and in hypertensive subjects. The changes observed in diastolic blood pressure (DBP) (WMD: −1.02 mmHg; 95% CI: −2.51, 0.46; P = 0.179) were not statistically significant. However, subgroup analysis showed that DBP decreased significantly in studies that enrolled hypertensive subjects or with elevated DBP (>80 mmHg). Lycopene supplementation reduced SBP in non-linear fashion based on dosage (P-nonlinearity = 0.04, Coef = −9.68). Conclusion The present study demonstrates the beneficial effects of lycopene supplementation on BP levels.

Background : Inflammation is defined as body tissues response to harmful stimuli. Obesity‑related inflammation leads to increased risk chronic diseases including diabetic polyneuropathy (DPN). The present study was performed to determine association between body mass index (BMI) and inflammatory markers including erythrocyte sedimentation rate (ESR) and C‑reactive protein (CRP) in DPN patients. Methods : In this cross‑sectional study, 200 DPN patients with a mean (SD) of age 58.76 (9.53) years were selected. All patients completed the questionnaire including demographic data and chronic disease history. In addition, anthropometric measures and clinical laboratory tests were taken. Multivariate linear regression was used to detect the association between BMI, CRP, and ESR levels. Results : BMI was associated with increase in ESR and CRP levels ( β ‑ESR = 4.67, P < 0.001 and β ‑CRP = 0.71, P < 0.001). Also, this association remained after adjustment for other different variables. Conclusions : These findings indicate that higher BMI is related to increase inflammatory markers including CRP and ESR in DPN patients. Therapies for DPN and reducing inflammation should target the weight loss among obese patients. Keywords : Body mass index, C‑reactive protein, diabetes, erythrocyte sedimentation rate, polyneuropathy

Growing evidence suggests beta-hydroxy-beta-methylbutyrate's (HMB) positive effects on recovery following exercise-induced muscle damage (EIMD). However, findings vary substantially across studies.A meta-analysis of randomized controlled trials was conducted to assess the effects of HMB supplementation on recovery following EIMD by assessing indirect markers of muscle damage, namely creatine kinase (CK) and lactate dehydrogenase (LDH) serum levels among healthy participants.A comprehensive search was performed on electronic databases (Medline, Scopus, Cochrane Library, and Google Scholar) up to October 2017 for trials evaluating the effects of HMB on recovery following EIMD. Mean ± standard deviation of follow-up CK and LDH concentrations were extracted to calculate the effect size for meta-analysis.A total of 324 participants for CK and 229 participants for LDH were found from the 10 and 8 studies, respectively. The results revealed a significant effect of HMB supplementation on CK (weighted mean difference [WMD] = -60.71 ULThe current evidence revealed a time-dependent effect of HMB in reducing LDH and CK serum levels among adults. HMB, therefore, may be seen as a priority muscle damage recovery agent in interventions.

BACKGROUND To relieve the signs and symptoms of anterior uveitis (AU), an ocular manifestation of Behcet's syndrome, we prescribed a synbiotic supplementation (probiotics and prebiotics) for a 49-year-old woman. CASE REPORT Seven strains of bacteria - Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, and Lactobacillus bulgaricus, each 10⁸ colony-forming units (CFU) - and fructo-oligosaccharide (FOS; 100 mg) were given as a capsule 2 times per day. After 7-month treatment, AU was improved and serum inflammatory markers - C-reactive protein (CRP), high-sensitivity CRP (hs-CRP), and estimated sedimentation rate (ESR) - were suppressed. Now, if a mild AU attack occurs, the problem is resolved by treatment with 1 gtt (from the Latin "guttae", meaning drops) eye drop (prednisolone 1%) for 1 week. CONCLUSIONS Synbiotic supplementation may contribute to treating AU, which is one of the most disastrous manifestations of BS, by controlling the proinflammatory processes.

Current evidence is debatable regarding the feasible effects of zinc supplementation on the inflammation and oxidative stress status of adults. This systematic review and meta-analysis aimed to clarify this inconclusiveness.Literature search was conducted via online databases such as PubMed, Scopus, ISI Web of Science, Cochrane Library, and Google Scholar until June 2020. The overall effect was presented as the weighted mean difference (WMD) at 95 % confidence interval (CI) in a random-effects meta-analysis model. Publication bias was also assessed using Egger's and Begg's statistics.In total, 25 clinical trials (n = 1428) were reviewed, which indicated that zinc supplementation significantly affects the concentration of C- reactive protein (WMD: -0.03 mg/l; 95 % CI: -0.06, 0.0; P = 0.029), interlukin-6 (WMD: -3.81 pg/mL; 95 % CI: -6.87, -0.76; P = 0.014), malondialdehyde (WMD: -0.78 μmol/l; 95 % CI: -1.14, -0.42; P0.001), and total antioxidant capacity (WMD: 95.96 mmol/l; 95 % CI: 22.47, 169.44; P = 0.010). In addition, a significant between-study heterogeneity and a non-significant increment was reported in nitric oxide (WMD: 1.47 μmol/l; 95 % CI: -2.45, 5.40; P = 0.461) and glutathione (WMD: 34.84 μmol/l; 95 % CI: -5.12, 74.80; P = 0.087).According to the results, zinc supplementation may have beneficial anti-inflammatory and anti-oxidative effects in adults.

Oxidative stress may play an important role in migraine pathogenesis. This randomized controlled trial aimed to investigate the effect of 12 weeks synbiotic supplementation on the oxidative stress and clinical symptoms of migraine in eighty women. The effect of the intervention on the total antioxidant capacity (TAC), nitric oxide (NO), oxidative stress index (OSI), total oxidant status (TOS), migraine index (MI), headache diary result (HDR) and migraine headache index score (MHIS) were investigated using bivariate comparison. Synbiotic supplementation improved TAC (381.77 vs 43.17 nmol/ml, P = 0.034), and reduced NO (-4.62 vs 0.55 nmol/ml, P = 0.021), OSI levels (-0.33 vs 0.0009, P = 0.027), and MI (-8.27 vs −3.20, P = 0.013) compared to placebo. A positive correlation between the severity of migraine headache and NO level was observed following synbiotic supplementation (r = 0.44, P = 0.002). Synbiotics may reduce oxidative stress and improve migraine symptoms in women and help as a supplemental therapy in managing migraine headaches.

Non-alcoholic fatty liver disease (NAFLD) is the most common emerging liver disease worldwide. Lifestyle modification is the most emphasized method on management of this disease.In order to conduct this parallel, randomized controlled trial study, eighty-two NAFLD patients recruited and allocated to intervention group or the control.After two months of intervention, significant improvements in all health belief model (HBM) variables and knowledge were seen within the intervention group (p 0.001) and also the improvements were significantly superior between two groups (p 0.001). Furthermore, prominent significant reduction for liver enzyme was observed in the intervention group compared to the controls. Similarly, ultra-sonographic findings revealed a significant improvement in the intervention group versus control.This HBM-based lifestyle modification education could be effective not only in the HBM domains but also in the improvement of NAFLD parameters. Therefore, it could be useful to use this educational program for NAFLD patients in order to impact on their beliefs and body together.Iranian Registry of Clinical Trials (IRCT2014101811763N17).

Background and purpose: Today, improving rheumatoid arthritis (RA) as a chronic inflammatory disease is attributed to the proper status of the gut microbiota. Although some supplements containing beneficial live microorganisms (probiotics) can reduce inflammation by altering the bacterial composition of the gut, there is limited information on the effect of synbiotic (probiotics mixed with prebiotics) supplements on RA. Therefore, this study aimed to evaluate the anti-inflammatory effects of a synbiotic supplement as an adjuvant therapy in rheumatic patients. Moreover, for the first time, it was attempted to investigate whether addition of a synbiotic (1000 mg/day) to the combination of methotrexate and prednisolone increases the effectiveness of these antirheumatic drugs. Experimental approach: Eligible patients (186 subjects) were randomly divided into two groups. Both groups received their standard routine antirheumatic drugs, methotrexate and prednisolone. Moreover, the first group received a daily oral synbiotic supplement (1000 mg) for 3 months while the second group received a placebo. Various parameters indicating RA status were evaluated at baseline (time 0) and 3 months after the treatment. Findings / Results: The results showed the changes in the level of RA indicators, including tender joint count with a range of 0 to 28 joints, swollen joint count with a range of 0 to 28 joints, visual analog scale, erythrocyte sedimentation rate, CRP, and disease activity score based on 28 joints, after 3 months Conclusion and implications: Overall, no significant differences in the measured parameters were observed between synbiotic and placebo groups probably due to the short duration of the treatment period, and it is suggested to extend the treatment period to six months.

Premenstrual syndrome (PMS) is a common disorder in the reproductive age that negatively significant impacts on women’s quality of life. This randomized clinical trial study was undertaken to investigate the effect of vitamin D supplementation on inflammatory and antioxidant markers in 44 vitamin D deficient (25(OH)D 3, Interleukin10 and 12 (IL-10, IL-12) and total antioxidant capacity (TAC). In vitamin D group, serum levels of IL-10 and IL-12 significantly decreased while TAC significantly increased post-intervention. There were significant differences regarding serum IL-12 and TAC levels between the two groups. Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS. This clinical trial was registered at Iranian Registry of Clinical Trials on 20/06/2018 (IRCT20180525039822N1).

There is a positive link between thyroid homeostasis and the composition of gut microbiota. A limited number of studies have suggested the efficacy of probiotic products on levothyroxine metabolism and thyroid hormone activity. Therefore, the purpose of this study was to investigate the effect of synbiotic supplementation on thyroid function, inflammation markers, and blood pressure in subjects with hypothyroidism.This study was conducted as a randomized, double-blind, placebo-controlled trial involving 60 patients with hypothyroidism. Participants were randomly recruited into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) for 8 weeks.Thyroid-stimulating hormone concentration, levothyroxine dose, and fatigue severity scale score were significantly decreased after the 8-week intervention in the synbiotic group (P 0.05), while there were no significant differences seen in the placebo group. In addition, FTSynbiotic supplementation among hypothyroid patients for 8 weeks may have beneficial effects on thyroid function. Further studies with larger sample size and longer duration are needed to confirm the current findings.

The relationship between thyroid hormones metabolism and trace element levels has biological plausibility; however, previous reports that compared trace element levels in patients with hypothyroidism and healthy individuals yielded conflicting results. Therefore, the aim of this meta-analysis was to investigate the association between selected trace elements (i.e., selenium (Se), zinc (Zn), iron (Fe), manganese (Mn), copper (Cu), lead (Pb)), and magnesium (Mg) concentrations in patients with hypothyroidism and healthy controls. Electronic databases, including PubMed, Scopus, Embase, and Science Direct, were searched systematically until September 2019. Thirty-two observational studies were included in the final analyses. Hedges' g tests were used to estimate effect sizes, as trace element concentrations were reported using different measurement units across the studies. Selenium (Hedges' g = - 0.52; 95% CI = [- 1.05, - 0.002]; P = 0.049) and Zn (Hedges' g = - 0.86; 95% CI = [- 1.66, - 0.06]; P = 0.035) concentrations were significantly lower, whereas Pb concentrations were significantly higher (Hedges' g = 0.34; 95% CI = [0.10, 0.59]; P = 0.006) in patients with hypothyroidism compared with healthy controls. There were no differences in the concentrations of Fe, Cu, Mn, and Mg between the groups. Patients with hypothyroidism exhibited lower Se and Zn and increased Pb concentrations compared with healthy controls. High-quality studies with larger sample sizes are required to explicate the link between trace element status and hypothyroidism.

Background: Enteral tube feeding intolerance (ETFI) is one of the most common complications of enteral nutrition (EN), which may lead to increased mortality and length of intensive care unit (ICU) stay. This study aimed to determine the prevalence of ETFI and effects on feeding intolerance on nutrition and clinical outcomes in Iran. Materials and Methods: This cross-sectional study was conducted in 2019 at the three general ICUs of Imam Reza Hospital in Mashhad, Iran, during 7 days on 245 patients. The collected data included demographic characteristics, primary diagnosis, the Acute Physiology and Chronic Health Evaluation II (APACHE ІІ) score, Sequential Organ Failure Assessment (SOFA) score, duration of mechanical ventilation, and length of ICU stay. Feeding intolerance was assessed using daily questionnaires for 7 days. ETFI was determined as the interruption of EN based on gastrointestinal causes, including large gastric residuals, abdominal distension, vomiting, diarrhea, and subjective discomfort. Results: Overall, 245 critically ill patients (122 males and 123 females) were included in this study, with a mean age of 58.43 ± 19.2 years in three general ICUs. The highest prevalence rate of ETFI was 91.8%, which occurred on the 2nd day although the rate decreased in the following days. The minimum ETFI was observed on the last day (38.8%). Feeding intolerance was associated with the increased APACHE II scores (P = 0.04), SOFA scores (P < 0.001), and duration of mechanical ventilation (P < 0.001) compared with the tolerant patients. The most common causes of ETFI in the patients admitted to the ICU were gastric residual volume (GRV), large GRV, vomiting, and distension. Conclusion: ETFI was prevalent in almost two-third (66%) of the critically ill patients receiving EN based on the GRV. ETFI was associated with deteriorated nutritional status and clinical outcomes.