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Background: Migraine headache is a major public health problem. Routine medications for migraine treatment are not useful in treating all patients and may have some side effects. The present study aimed to investigate the effect of vitamin D and probiotic co-supplementation on clinical characteristics of migraine, daily functioning, mental health outcomes, and serum levels of high-sensitivity C-reactive protein (hs-CRP)., Methods: In this randomized, triple-blinded, placebo-controlled trial, patients aged 18 to 55 years diagnosed with migraine based on the International Classification of Headache Disorders-3 (ICHD-3) were randomized to either vitamin D (50,000 IU every 2 weeks) plus probiotic (4.5 × 10 11  CFU per day) or placebo for 12 weeks. The Headache Impact Test (HIT-6) and Depression, Anxiety, and Stress Scale (DASS) questionnaires were administered to patients at baseline and after 12 weeks. In addition, the frequency, duration, and severity of migraine headaches per month were assessed using a self-administered 30-day headache diary at baseline and the end of the intervention. Anthropometric indices, blood pressure, and serum levels of 25-hydroxy vitamin D and hs-CRP were also examined at first and the end of the study., Results: Seventy-two migraine patients with a mean age of 37.46 ± 8.32 years were included in this trial. Probiotic and vitamin D co-supplementation compared to placebo resulted in a significant increase in serum levels of vitamin D (+ 12.86 ± 1.64 vs. + 1.12 ± 0.80 ng/mL, P < 0.001). The between-group analysis in the adjusted model showed a significantly greater reduction in migraine headache frequency (- 3.17 ± 0.84 vs. - 1.25 ± 0.34; P = 0.031) and severity (- 1.55 ± 0.35 vs. + 0.67 ± 0.29; P = 0.017) in the probiotic and vitamin D group than the placebo group. No significant difference was found between the two arms of the intervention regarding the change in headache duration, hs-CRP, scores of DASS, and HIT-6 questionnaires (P > 0.05)., Conclusions: This trial showed that probiotic and vitamin D co-supplementation for 12 weeks has beneficial effects on migraine headache characteristics. Further research is needed to confirm this finding., (© 2024. The Author(s).)

Background: Migraine is a severe neurological disorder that is recognized as one of the most common debilitating diseases worldwide. Although the exact cause of migraine is not known, research suggests that inflammation, oxidative stress, mitochondrial dysfunction, and insufficient nutrients may contribute to its development. Studies indicate that nutrition-based approaches are safer and more cost-effective strategies for managing migraine symptoms compared to medication. In this regard, the impact of nutrition, as a complementary medicine, is largely attributed to that of certain nutrients on inflammation and mitochondrial function. It is hypothesized that alpha-linolenic acid and L-carnitine, which possess anti-inflammatory and antioxidant properties, may be synergically beneficial for migraine patients. Therefore, this study will be conducted to assess the efficacy of alpha-linolenic acid and L-carnitine co-supplementation in patients with migraine., Methods: This is a parallel, randomized, triple-blind, placebo-controlled clinical trial, in which 80 women aged 20 to 50 years with migraine will be assigned to receive either intervention group (n = 40) receiving both 1000 mg/day flaxseed oil and 500 mg/day L-carnitine simultaneously for 12 weeks, or control group (n = 40) receiving both 1000 mg/day paraffin oil and 500 mg/day maltodextrin as the placebos for the same duration. The primary outcomes include changes in clinical symptoms of migraine, including frequency, severity, and duration of attacks, serum levels of C-reactive protein (CRP), total antioxidant capacity (TAC), nitric oxide (NO), malondialdehyde (MDA), and superoxide dismutase (SOD). Secondary outcomes include mental health, sleep quality, and quality of life (QOL)., Discussion: In this study, we aim to investigate the potential benefits of combining alpha-linolenic acid and L-carnitine as a treatment option for migraine sufferers. Migraine, characterized by recurrent severe headaches, affects a significant portion of the population and can significantly impact an individual's quality of life. By studying alternative therapies such as alpha-linolenic acid and L-carnitine, researchers hope to expand the range of treatment options available and potentially provide relief to migraine sufferers., Trial Registration: Iranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20121216011763N57). Registration date: 29 March 2023., Trial Status: The protocol is version 1.0 dated December 30, 2023. Recruitment began on July 10, 2023, and is expected to be completed by January 22, 2024., (© 2024. The Author(s).)

Background: Multiple trauma has serious complications, which increases the risk of morbidity and mortality in the patients. This study aimed to evaluate the impact of supplementation with phytosomal curcumin on clinical and laboratory factors in critically ill patients with multiple trauma., Methods: In this double-blind trial, 53 patients with multiple trauma, who were admitted to the intensive care unit (ICU) were randomized to receive either 2 capsules, each capsule containing 250 mg phytosomal (a total of 500 mg daily) as an intervention group or 2 identical capsules (placebo capsules), each containing 250 mg maltodextrin for 7 days. Clinical and laboratory were parameters assessed before and after the intervention., Results: After seven days of intervention, the mean increase from baseline in the Glasgow coma scale (GCS) score was significantly higher in the curcumin compared with the placebo group (P-value: 0.028), while the reduction in the APACHE-II score in the curcumin group was greater than that the placebo group in a marginally non-significant fashion (P-value: 0.055). Serum total bilirubin (P-value: 0.036) and quantitative C-reactive protein (CRP) (P-value: 0.044) levels significantly decreased while potassium (P-value: 0.01) significantly increased in the curcumin compared with the placebo group. Moreover, supplementation with phytosomal curcumin significantly increased platelet count (P-value: 0.024) as compared with placebo. The 28-day mortality rate was 7.7% (n: 2 patients) and 3.7% (n: 1 patients) in the placebo and curcumin groups, respectively (P-value > 0.05)., Conclusion: Phytosomal curcumin had beneficial effects on several clinical and laboratory factors including GCS, APACHEII, serum total bilirubin, CRP, and platelet count in ICU-admitted patients with multiple trauma., Trial Registration: IRCT20090306001747N1, Available on: https://www.irct.ir/trial/52692 . The first registration date was 12/01/2021., (© 2024. The Author(s).)

Background: Despite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a beneficial effect on migraine outcomes. However, no study has explored the effects of selenium supplementation on migraine symptoms, oxidative stress biomarkers, and mental health. Therefore, this randomized, double-blinded, placebo-controlled clinical trial aims to examine the effects of selenium supplementation among migraine patients., Methods: Seventy-two migraine patients will receive either 200 µg/day selenium supplement (n = 36) or placebo (n = 36) for 12 weeks in a randomized, double-blinded, placebo-controlled study. The severity, frequency, and duration of headaches, mental health indices including depression, anxiety, and distress, and quality of life, as well as biomarkers of oxidative stress such as nitric oxide (NO), malondialdehyde (MDA), total antioxidant capacity (TAC), and total oxidant status (TOS), will be measured at the baseline and end of the study. The intention-to-treat (ITT) approach will be used to estimate missing values. One-way analysis of covariance (ANCOVA) will be performed to detect the effect of selenium supplementation on outcome variables., Discussion: Oxidative stress is recognized as a key contributor to migraine pathogenesis. Selenium is an essential trace element with antioxidant properties, capable of crossing the blood-brain barrier (BBB), holding promise to alleviate the oxidative stress and neurotoxicity. Thus, selenium may beneficially affect clinical symptoms and oxidative stress as well as the quality of life in migraine patients., Trial Registration: This trial was registered in the Iranian Registry of Clinical Trials ( https://www.irct.ir/ ) on 27 May 2023 with the code number IRCT20121216011763N60., (© 2024. The Author(s).)

Background: Sepsis, a life-threatening organ dysfunction caused by a host's dysregulated response to infection with an inflammatory process, becomes a real challenge for the healthcare systems. L-carnitine (LC) has antioxidant and anti-inflammatory properties as in previous studies. Thus, we aimed to determine the effects of LC on inflammation, oxidative stress, and clinical parameters in critically ill septic patients., Methods: A randomized double-blinded controlled trial was conducted. A total of 60 patients were randomized to receive LC (3 g/day, n = 30) or placebo (n = 30) for 7 days. Inflammatory and oxidative stress parameters (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), 28-day mortality rate, and some monitoring variables were evaluated., Results: There was no statistically significant difference between study arms in baseline characteristics and disease severity scores. CRP (p < 0.001) and ESR (p: 0.004) significantly reduced, and SOD (p < 0.001) and TAC (p < 0.001) significantly improved in the LC group after 7 days. Between-group analysis revealed a significant reduction in CRP (p: 0.001) and serum chloride (p: 0.032), an increase in serum albumin (p: 0.036) and platelet (p: 0.004) significantly, and an increase in SOD marginally (p: 0.073). The 28-day mortality rate was also lower in the LC group compared with placebo (7 persons vs. 15 persons) significantly (odds ratio: 0.233, p: 0.010)., Conclusions: L-carnitine ameliorated inflammation, enhanced antioxidant defense, reduced mortality, and improved some clinical outcomes in critically ill patients with sepsis., Trial Registration: IRCT20201129049534N1; May 2021., (© 2024. The Author(s).)

Background: Burn injuries are important medical problems that, aside from skin damage, cause a systemic response including inflammation, oxidative stress, endocrine disorders, immune response, and hypermetabolic and catabolic responses which affect all the organs in the body. The aim of this study was to determine the effect of coenzyme Q10 (CoQ10) supplementation on inflammation, oxidative stress, and clinical outcomes in burn patients., Methods: In a double-blind placebo-controlled randomized clinical trial, 60 burn patients were randomly assigned to receive 100 mg CoQ10 three times a day (total 300 mg/day) or a placebo for 10 days. Inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), oxidative stress markers including total antioxidant capacity (TAC), malondialdehyde (MDA) and superoxide dismutase (SOD) activity, fasting blood glucose (FBG), blood urea nitrogen (BUN), creatinine, white blood cells (WBC), and body temperature were assessed as primary outcomes and albumin, prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR), other hematological parameters, blood pressure, O 2 saturation, ICU duration, and 28-mortality rate were assessed as secondary outcomes., Results: Fifty-two participants completed the trial. CRP and ESR levels were not significantly different between CoQ10 and placebo groups at the end of the study (P = 0.550 and P = 0.306, respectively). No significant differences between groups were observed for TAC (P = 0.865), MDA (P = 0.692), and SOD activity (P = 0.633) as well. Administration of CoQ10 resulted in a significant increase in albumin levels compared to placebo (P = 0.031). There was no statistically significant difference between the two groups in other measured outcomes (P > 0.05)., Conclusion: Results showed that in patients with burn injury, CoQ10 administration had no effect on inflammatory markers and oxidative stress, although serum albumin levels were improved after supplementation. Further studies with albumin as the primary outcome are needed to confirm this finding., (© 2024. The Author(s).)

Background: Stroke is a leading cause of death worldwide, which is associated with a heavy economic and social burden. The purpose of this study was to investigate the effects of supplementation with curcumin-piperine combination in patients with ischemic stroke in the rehabilitation stage., Methods: In this randomized controlled trial, 66 patients with stroke were randomized into two groups receiving curcumin-piperine tablets (500 mg curcumin + 5 mg piperine) and matched placebo tablets for 12 weeks. High-sensitivity C-reactive protein (hs-CRP), carotid intima-media thickness (CIMT), thrombosis, total antioxidant capacity (TAC), lipid profile, anthropometric indices, blood pressure, and quality of life were assessed before and after the intervention. Statistical data analysis was done using SPSS22 software., Results: A total of 56 patients with a mean age of 59.80 ± 4.25 years completed the trial. Based on ANCOVA test, adjusted for baseline values, curcumin-piperine supplementation for 12 weeks resulted in significant reductions in serum levels of hs-CRP (p = 0.026), total cholesterol (TC) (p = 0.009), triglycerides (TG) (p = 0.001), CIMT (p = 0.002), weight (P = 0.001), waist circumference (p = 0.024), and systolic and diastolic blood pressure (p < 0.001), and a significant increase in TAC (p < 0.001) in comparison to the placebo. Pain score significantly increased in both groups; however, its increase was significantly higher in the placebo group compared with the intervention group (p = 0.007). No significant changes were observed between the two groups in terms of serum fibrinogen, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and quality of life indices., Conclusion: Curcumin-piperine supplementation had beneficial effects on CIMT, serum hs-CRP, TC, TG, TAC, and systolic and diastolic blood pressure in patients with ischemic stroke in the rehabilitation stage., (© 2023. The Author(s).)

Background: Migraine is a complex, chronic, and debilitating multifactorial disorder characterized by recurrent episodes of headache and related symptoms. It typically begins in early ages and is more prevalent in women than in men. Recently, the gut-brain axis has emerged as a new candidate that may be linked to neurological diseases. We hypothesize that selective modulation of the intestinal microbiota, oxidative stress, and inflammation through inulin supplementation may improve clinical outcomes in these patients. Therefore, this study aims to examine the effects of high-performance inulin supplementation on clinical symptoms, mental health, quality of life (QOL), intestinal permeability, and inflammatory and oxidative stress factors in women with migraine., Methods: This is a randomized, double-blind, placebo-controlled clinical trial involving 80 women with migraine who meet the inclusion criteria (aged between 20 and 50 years with a diagnosis of migraine by a neurologist based on the ICDH-3). Participants will be assigned to receive a daily dose of 10 g of inulin for 12 weeks (intervention group, n = 40) or 10 g of maltodextrin as a placebo for the same duration (control group, n = 40). The primary outcome will measure the variations in the frequency of headache experienced by the patients. Secondary outcomes will encompass serum levels of zonulin, high-sensitive C-reactive protein, total antioxidant capacity, total oxidant status, nitric oxide, mental status, QOL, duration, and severity of migraine attacks., Discussion: This clinical trial aims to evaluate the effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms, mental health, and QOL in women with migraine. The findings of this trial could contribute to the identification of mechanistic action and evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in the management of clinical outcomes in migraine patients., Trial Registration: Iranian Registry of Clinical Trials ( www.irct.ir ) (ID: IRCT20121216011763N58). Registration date: 23 April 2023., Trial Status: The protocol is version 3.0, September 17, 2023. Recruitment began August 21, 2023, and is anticipated to be completed by March 22, 2024., (© 2023. The Author(s).)

Objectives: Pervious epidemiologic evidence indicates that soluble fiber is protective against hypertention: however, randomized controlled trials (RCTs) have presented varying results. In the present study, we aimed to conduct a systematic review and dose-response meta-analysis to summarize published RCTs which assess the effect of soluble fiber supplementation on systolic blood pressure (SBP) and diastolic blood pressure (DBP)., Methods: Scopus, PubMed, and ISI Web of Sciences were searched to identify relevant studies up to Aug 2022. We estimated the change in blood pressure for each 5 g/d increment in soluble fiber supplementation in each trial and then calculated the weighted mean difference (WMD) and 95%CI using a random-effects model. We estimated dose-dependent effects using a dose-response meta-analysis of differences in means. The risk of bias for study was assessed using the Cochrane tool. Publication bias was evaluated via funnel plot and Begg's test and Egger's test., Results: Eighty-three eligible studies with total sample size of 5,985 participants were included in the meta-analysis. Soluble fiber supplementation significantly decreased SBP (WMD: -1.36 mmHg, 95% CI: -2.13 to -0.60, P < 0.001; I 2  = 47.1%, P < 0.001) and DBP (WMD: -0.72 mmHg, 95% CI: -1.26 to -0.18, P = 0.009; I 2  = 45.4%, P < 0.001). Each 5 g/d increment in soluble fiber supplementation had a significant reduction in SBP (WMD: -0.54 mmHg; 95%CI: -0.86, -0.22, P = 0.001; I 2  = 52.2, P het  < 0.001) and DBP (WMD: -0.28 mmHg; 95%CI: -0.49, -0.80, P = 0.007; I 2  = 43.1%, P het  < 0.001). The levels of SBP decreased proportionally with the increase in soluble fiber supplementation up to 20 g/d (MD 20g/d : -1.79 mmHg, 95%CI: -2.86, -0.71)., Conclusion: Current evidence indicated the beneficial effect of soluble fiber supplementation on blood pressure. Our findings suggest that soluble fiber supplementation could contribute to the management of hypertension and the reduction of cardiovascular disease risk., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted., Methods: This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation., Discussion: Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 μg/day, it has not had any significant side effects in many types of cancer under radiation therapy., Trial Registration: Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Primary hypothyroidism is a common endocrine disorder caused by impaired production of thyroid hormones. Recent studies have shown that dietary habits, oxidative stress, and inflammation may play roles in thyroid hypofunction. Thus, the present article aimed to determine the relationship between major dietary patterns and oxidative stress and inflammation in primary hypothyroid patients and healthy people in Iranian adults., Methods: This matched case-control study was conducted on 200 participants (100 cases and 100 controls). The presence of primary hypothyroidism was determined by endocrinologists based on American Thyroid Association (ATA) criteria. Dietary intake was assessed using a validated 168-item, semi-quantitative food frequency questionnaire (FFQ). The principal component analysis (PCA) method was used to derive major dietary patterns. Statistical analysis was performed using logistic regression analysis, and the findings were reported using odds ratios (ORs) with 95% CIs., Results: We identified 2 major dietary patterns (i.e., healthy and Western dietary patterns). After adjusting for confounding variables, participants in the highest tertile of the healthy eating pattern had lower odds of primary hypothyroidism. Also, there was a significant relationship between total antioxidant capacity (TAC) levels and thyroid hypofunction; however, no significant correlation was seen between the Western dietary pattern and malondialdehyde (MDA) and C-reactive protein (CRP) with hypothyroidism., Conclusions: There were statistically direct associations between healthy dietary patterns (loaded with vegetables, nuts and seeds, fruits, dried fruits, olives, garlic, black pepper, starchy vegetables, low-fat dairy, and legumes) and increased TAC levels with a decreased risk of thyroid hypofunction. However, Western dietary patterns and MDA and CRP levels did not associate with an underactive thyroid., (© 2023. The Author(s).)

Background: Observational studies have reported that dietary renal acid load has an important role in insulin resistance and metabolic factors. The aim of the present study was to assess the effect of a low renal acid load diet (LRALD) on blood pressure, lipid profile, and blood glucose indices in patients with type 2 diabetes., Methods: In this parallel randomized clinical trial, 80 patients with type 2 diabetes were randomly assigned to the LRALD (n = 40) or control (n = 40) groups, for 12 weeks. Both groups received a balanced diet and a list of nutritional recommendations based on healthy eating behaviors. In the LRALD group, food items with low renal acid load were prescribed. Primary outcomes including: fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting serum insulin, quantitative insulin sensitivity check index (QUICKI), homeostatic model assessment for insulin resistance (HOMA) and secondary outcomes including: weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). were measured at baseline and end of the study. The present trial was registered at IRCT.ir (IRCT20130903014551N5)., Results: Seventy subjects completed the study (n = 35 in control group and n = 36 in LRALD). Weight (P < 0.001), body mass index (P < 0.001), FBG (P < 0.001), HbA1c (P < 0.001), SBP (P = 0.004), and TG (P = 0.049) were reduced and HDL (P = 0.002) was increased in both groups, compared with baseline. After adjusting for baseline values, DBP (P = 0.047) was reduced in the LRALD group compared with control group. Results had no changes after using intention to treat analysis., Conclusion: A LRALD may decrease DBP in type 2 diabetic patients. However, it elicited no significant effect on lipid profile compared with a healthy diet., Trial Registration: This randomized clinical trial was registered at IRCT.ir (IRCT20130903014551N5)., (© 2023. The Author(s).)

Dietary factors may play a role in the etiology of endometriosis and dietary intake of some food groups and nutrients could be associated with endometriosis risk. This systematic review and meta-analysis of observational studies was conducted to summarize the findings on the association between dietary intakes of selected food groups and nutrients (dairy, fats, fruits, vegetables, legumes, and animal-derived protein sources), and the risk of endometriosis among adult women. PubMed, Scopus, and ISI Web of Science were systematically searched up to September 2022. The inverse variance-weighted fixed-effect method was used to estimate the effect size and corresponding 95% CI. A total of 8 publications (4 studies) including 5 cohorts and 3 case-control with a sample size ranging from 156 to 116,607 were included in this study. A higher intake of total dairy [all low-fat and high-fat dairy foods] was associated with decreased risk of endometriosis (RR 0.90; 95% CI, 0.85 to 0.95; P < 0.001; I 2  = 37.0%), but these associations were not observed with intakes of low or high-fat dairy, cheese or milk. Increased risk of endometriosis was associated with higher consumption of red meat (RR 1.17; 95% CI, 1.08 to 1.26; P < 0.001; I 2  = 82.4%), trans fatty acids (TFA) (RR 1.12; 95% CI, 1.02 to 1.23; P = 0.019; I 2  = 73.0%), and saturated fatty acids (SFA) (RR 1.06; 95% CI, 1.04 to 1.09; P < 0.001; I 2  = 57.3%). The results of this meta-analysis suggest that there may be differing associations between dietary intake of dairy foods, red meat, SFAs, and TFAs and the risk of endometriosis. It may be useful to extend the analysis to other types of food groups and dietary patterns to obtain a complete picture. Additionally, further investigations are needed to clarify the role of diet in the incidence and progression of endometriosis.Trial registration: PROSPERO, CRD42020203939., (© 2022. The Author(s).)

Background: Abnormal uterine bleeding (AUB), alopecia, low quality of life, and acne are considered as complications of polycystic ovary syndrome (PCOS). We hypothesized that magnesium supplementation would yield beneficial effects on PCOS related complications., Objective: To examine the effects of magnesium supplementation on AUB, alopecia, quality of life, and acne., Methods: In this parallel randomized clinical trial, we randomly assigned 64 women with PCOS to the magnesium group (n = 32) or placebo group (n = 32) for 10 weeks. AUB, alopecia, quality of life, and acne were assessed by the International Federation of Gynecology and Obstetrics criterion, the Sinclair Scale, the Health Survey Quality of Life Questionnaire, and the Global Acne Grading System, respectively. This randomized clinical trial was registered at IRCT.ir (IRCT20130903014551N9)., Results: Magnesium supplementation significantly improved the components of quality of life including physical functioning (p = 0.011), role limitations due to physical health (p = 0.012), role limitations due to emotional problems (p < 0.001), energy/fatigue (p = 0.005), emotional wellbeing (p < 0.001), social functioning (p = 0.002), general health (p = 0.013), and total quality of life (p < 0.001), compared with placebo. No significant effect was observed on acne, alopecia, and AUB., Conclusion: Magnesium supplementation in women with PCOS had a significant positive effect on improving total quality of life., Trial Registration: This randomized clinical trial was registered at IRCT.ir on 2020-10-18 (Registration Code: IRCT20130903014551N9 )., (© 2022. The Author(s).)

Background: Literature suggests a relationship between estrogen levels and migraine headache pathogenesis. However, the effect of soy isoflavones on migraine characteristic remains unclear. This study aimed to investigate the effect of soy isoflavones on migraine characteristics and calcitonin gene-related peptide (CGRP) levels in women with migraine., Methods: Eighty-three participants completed a randomized double-blind controlled trial, receiving 50 mg per day soy isoflavones or placebo supplementation for 8 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, mental status, quality of life and serum CGRP levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis., Results: Soy isoflavones intake resulted in a significant decrease in mean frequency (-2.36 vs -0.43, P < 0.001), duration (-2.50 vs -0.02, P < 0.001) of migraine attacks and CGRP level (-12.18 ng/l vs -8.62, P = 0.002) in compared to placebo group. Also, a significant improvement was found in quality of life (16.76 vs 2.52, P < 0.001). Although, reduction in the migraine severity and mental status did not reach a statistically significant level (P > 0.05)., Conclusion: soy isoflavones supplementation may be considered as a complementary treatment for women with migraine to improve migraine characteristics and reduce the burden of disease., (© 2022. The Author(s).)

Background: COVID-19 pandemic has made the disease a major global problem by creating a significant burden on health, economic, and social status. To date, there are no effective and approved medications for this disease. Curcumin as an anti-inflammatory agent can have a positive effect on the control of COVID-19 complications. This study aimed to assess the efficacy of curcumin-piperine supplementation on clinical symptoms, duration, severity, and inflammatory factors in patients with COVID-19., Methods: Forty-six outpatients with COVID-19 disease were randomly allocated to receive two capsules of curcumin-piperine; each capsule contained 500 mg curcumin plus 5 mg piperine or placebo for 14 days., Results: Mean changes in complete blood count, liver enzymes, blood glucose levels, lipid parameters, kidney function, and c-reactive protein (CRP) were not significantly different between the two groups. There was a significant improvement in health status, including dry cough, sputum cough, ague, sore throat, weakness, muscular pain, headache, and dyspnea at week 2 in both curcumin-piperine and placebo groups (P value < 0.05); however, the improvement in weakness was more in the curcumin-piperine group than with placebo group (P value 025)., Conclusion: The present study results showed that curcumin-piperine co-supplementation in outpatients with COVID-19 could significantly reduce weakness. However, in this study, curcumin-piperine co-supplementation could not significantly affect the other indices, including biochemical and clinical indices., Trial Registration: Iranian Registry of Clinical Trials IRCT20121216011763N46 . 2020-10-31., (© 2022. The Author(s).)

Objectives: Based on a comprehensive search, we realized that there is no previous study conducted among migraine patients to assess the association between major dietary patterns and mental health. Therefore, the present study aims to explore the relationship between empirically-derived dietary patterns and depression, anxiety, and stress in a sample of Iranian migraine patients., Methods: A total of 262 migraine patients (20-50 years) were selected through simple random sampling method for this study. Dietary intake during the previous year was determined using a validated 168-item, semi-quantitative food frequency questionnaire (FFQ), and major dietary patterns were derived using principal component analysis (PCA). For mental health evaluation, authors used the Depression, Anxiety, and Stress Scales (DASS- 21) questionnaire. Statistical analysis included multinomial logistic regression analysis and results were expressed as odds ratio (OR) with a 95% confidence interval (CI)., Results: We identified three major dietary patterns including "traditional", "western", and "healthy". After controlling for potential confounders, those in the highest tertile of the healthy dietary pattern had lower odds of depression (OR = 0.44, 95% CI: 0.22, 0.88; P for trend: 0.030) and stress (OR = 0.50, 95% CI: 0.25, 0.99; P for trend: 0.049). However, no significant association was observed between western and traditional dietary patterns and mental disorders., Conclusions: In summary, significant associations were documented between healthy dietary patterns and risk of depression and stress. Current findings urge migraine patients to increase their intakes of fruits, vegetables, eggs, whole grains, nuts and seeds, meat, and poultry and reduce the intake of fast foods and snacks, processed meat, fish, cola drink, condiments, dairy, and vegetable pickles to diminish the chance of depression and stress., (© 2022. The Author(s).)

Background: Sepsis is a common cause for admission to the intensive care unit (ICU), and its incidence has been increasing. It is associated with a significant increase in serum inflammatory biomarkers such as C-reactive protein (CRP) and cytokines such as interleukin 1 (IL-1), IL-6, and tumor necrosis factor (TNF). Sepsis is also associated with pathophysiological changes that include fluid accumulation in the lungs, eventually leading to acute respiratory distress syndrome (ARDS), tissue edema, hypotension, and acute kidney injury (AKI). Conventional therapies include antibiotics, but these may have important adverse effects, so novel therapeutic approaches are required. In animal studies, L-carnitine improves antioxidant status, and in some clinical trials, it has been shown to reduce inflammation. It has also been shown to improve respiratory distress and help maintain coenzyme A homeostasis, metabolic flexibility, promoting the normal function of the tricarboxylic acid (TCA) cycle, and oxidation of fatty acids by peroxisomes. We aim to determine the effects of very high doses of L-carnitine on inflammatory factors, oxidative stress, and clinical outcomes of patients with sepsis in ICU., Method and Design: In this double-blind, randomized controlled clinical trial, we will use block randomization of 60 patients with sepsis, aged between 20 and 65 years from Al-Zahra Hospital, Isfahan, Iran. The intervention group (n = 30) will receive three capsules of L-carnitine (each capsule contains 1000 mg L-carnitine; totally 3000 mg/day) for 7 days, and a control group (n = 30) will receive a placebo with the same dose and for the same duration in addition to usual care. At baseline, scores for clinical and nutritional status (Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), Quick SOFA (qSOFA), and NUTRIC Score) will be assessed. At beginning and end point of the study, inflammatory markers (CRP, erythrocyte sedimentation rate (ESR)), oxidative stress status (total oxidative stress (TOS), total antioxidant capacity (TAC)), and clinical variables will be evaluated also. The mortality rate will be assessed within 28 days of the beginning of the intervention., Discussion: Because of the anti-inflammatory and antioxidant properties of L-carnitine, it is possible that using a high dose of 3000 mg daily of this nutritional supplement may reduce inflammation and oxidative stress and improve subsequent mortality of critically ill patients with sepsis., Trial Registration: Iranian Registry of Clinical Trials IRCT20201129049534N1 . Registered on 2 May 2021., (© 2022. The Author(s).)

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; I 2  = 99.9%), Hashimoto's thyroiditis (HT) (WMD - 6.05 ng/dl; 95% CI, - 8.35 to - 3.75; P < 0.001; I 2  = 91.0%) and hypothyroidism patients (WMD - 13.43 ng/dl; 95% CI, - 26.04 to - 0.81; P = 0.03; I 2  = 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; I 2  = 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., (© 2021. The Author(s).)

Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD., Methods: We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children's mental health at baseline and the end of the study., Results: After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo., Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed., Trial Registration: IRCT2016030326886N1 .

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 .

Cardiovascular diseases (CVDs) are globally the major causes of morbidity and mortality. Evidence shows that smaller and denser low-dense lipoprotein (sdLDL) particles are independent atherogenic risk factors for CVD due to their greater susceptibility to oxidation, and permeability in the endothelium of arterial walls. sdLDL levels are an independent risk factor and of more predictive value than total LDL-C for the assessment of coronary artery disease and metabolic syndrome. Functional food ingredients have attracted significant attention for the management of dyslipidemia and subsequently increase cardio-metabolic health. However, to date there is no study that has investigated the effect of these bioactive natural compounds on sdLDL levels. Therefore, the aim of the present review is to summarize the evidence accrued on the effect of special dietary ingredients such as omega-3 polyunsaturated fatty acids, nutraceuticals and herbal medicines on the levels of sdLDL, LDL particle number, and LDL particle size. Based on the results of the existing clinical trials this review suggests that natural products such as medicinal plants, nutraceuticals and omega-3 fatty acids can be used as adjunct or complementary therapeutic agents to reduce sdLDL levels, LDL particle numbers or increase LDL particle size and subsequently may prevent and treat CVD, with the advantage that theses natural agents are generally safe, accessible, and inexpensive.