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The acknowledgment in the original article is incomplete. [ABSTRACT FROM AUTHOR]

Recently Eshaghi et al. introduced orthogonal sets and proved the real generalization of the Banach fixed point theorem on these sets. In this paper, we prove the real generalization of Diaz–Margolis fixed point theorem on orthogonal sets. By using this fixed point theorem, we study the stability of orthogonally ∗ -m-homomorphisms on Lie C ∗ -algebras associated with the following functional equation: f (2 x + y) + f (2 x - y) + (m - 1) (m - 2) (m - 3) f (y) = 2 m - 2 [ f (x + y) + f (x - y) + 6 f (x) ]. for each m = 1 , 2 , 3 , 4. . Moreover, we establish the hyperstability of these functional equations by suitable control functions. [ABSTRACT FROM AUTHOR]

This study aimed to review the potential neuroprotective effects and underlying mechanisms of fasting in neurodegenerative disorders by synthesizing the existing literature. Research indicates that fasting may induce substantial modifications in both brain structure and function through diverse metabolic and cellular pathways. Preclinical studies utilizing animal models have elucidated several key mechanisms mediating these effects. The other significant proposed mechanism involves the modulation of gut microbiota during fasting periods. The intestinal microbiome functions as a crucial intermediary in the complex interplay between feeding patterns, circadian rhythms, and immune responses. These microbiome alterations may subsequently exert considerable influence on central nervous system functionality. Moreover, by reducing glucose availability, fasting has been shown to enhance the survival and resistance of healthy cells to adjuvant treatments in central nervous system tumors. Fasting presents a promising non-pharmacological intervention for neurodegenerative disorders, potentially offering both preventive and therapeutic benefits. However, the current evidence base remains preliminary, warranting extensive further investigation to validate these initial findings and establish robust clinical protocols for both efficacy and safety., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) is to investigate the overall effects of zinc supplementation on lipid profile and body composition such as body weight (BW), body mass index (BMI), triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), and high-density lipoprotein-cholesterol (HDL-C) in patients with type 2 diabetes mellitus (T2DM). Scopus, Web of Science, PubMed, and Embase databases were searched from inception through October, 2023. The I 2 and Cochran's Q tests were used to assess heterogeneity between studies. Nineteen RCTs (n = 1357 participants) were included in the meta-analysis. Zinc supplementation significantly reduced TG (WMD = - 17.41 mg/dL; 95% CI: - 22.60, - 12.22; P < 0.001), TC (WMD: - 19.60 mg/dL; 95% CI: - 28.46, - 10.73, P < 0.001), LDL-C (WMD = - 8.80 mg/dL; 95% CI: - 14.80, - 2.81; P = 0.004), and BMI (WMD = - 0.53 kg/m 2 ; 95% CI: - 1.05, - 0.01; P = 0.046) but not BW (WMD: - 0.51 kg, 95 % CI: - 1.99, 0.97, P = 0.498). Moreover, zinc supplementation increased HDL-C (WMD = 4.82 mg/dL; 95% CI: 0.88, 8.76; P = 0.016) in patients with T2DM. Our results propose that zinc supplementation may be an effective strategy for improving lipid profile and body composition in patients with T2DM., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Aims: In this study, we aimed to evaluate the relationship between the dietary inflammatory index (DII) and mental health outcomes among patients with migraine headaches., Methods: In this cross-sectional study, 262 subjects were included. The dietary intakes were collected using a validated 168-item semi-quantitative food frequency questionnaire. Items were scored according to their inflammatory potential, so a higher DII indicated a more pro-inflammatory diet. The association between DII and the mental health of participants was investigated using multinomial logistic regression and odds ratio (OR) with a corresponding 95% confidence interval (CI) was reported., Results: Overall, 224 women and 38 men, with a mean (standard error) DII of -2.96 (0.06), age of 36.1 (0.53) years, and BMI of 25.55 (0.21) kg/m 2 , comprised our study population. DII was positively associated with a higher risk of depression in patients with the highest adherence to a pro-inflammatory diet compared to those with the lowest adherence (OR = 1.76; 95%CI: 1.04, 3.00; P trend  = 0.035). Adjustments for age, sex, marital status, smoking status, migraine headache index score, number of family members, mean arterial pressure, medication, physical activity, and BMI intensified the association in a way that the risk of depression was 2.03 times higher in patients with the highest adherence to a pro-inflammatory diet compared to those with the lowest adherence to a pro-inflammatory diet (OR = 2.03; 95%CI: 1.18, 3.49; P trend  = 0.011)., Conclusion: Our findings suggest that depression was positively associated with adherence to a pro-inflammatory diet. However, no significant association was observed between anxiety and stress with DII.

Type 2 diabetes mellitus (T2DM) is a metabolic disorder associated with insulin resistance and ensuing dysglycemia, dyslipidemia, and inflammation. Owing to the putative metabolic benefits of curcumin-piperine combination, we explored the efficacy of this combination in improving cardiometabolic indices of patients with T2DM and hypertriglyceridemia. In this double-blind clinical trial, 72 patients with T2DM and hypertriglyceridemia were randomized to receive either a tablet containing 500 mg of curcuminoids plus 5 mg of piperine, or a matched placebo for 12 weeks. Anthropometric indices, blood pressure, glycemic indices, lipid profile, C-reactive protein (CRP), quality of life, and mood were evaluated at baseline and end of the study. After 12 weeks of intervention, the levels of triglycerides (p-value = 0.001) and fasting blood glucose (p-value = 0.004) were significantly reduced in the curcumin-piperine compared with the placebo group. CRP levels were marginally reduced in the curcumin-piperine compared with the placebo group (p-value = 0.081). In addition, energy/fatigue significantly increased in the curcumin-piperine group compared to the control group (p-value = 0.024). However, between-group comparisons showed no significant change in other parameters, including anthropometric indices (waist circumference and body mass index (BMI)), biochemical parameters (low-density lipoprotein (LDL-c), high-density lipoprotein (HDL-c), and insulin), HOMA-IR, blood pressure, quality of life, and DASS-21 items between the studied groups (p-value >0.05). The current study showed that curcumin-piperine supplementation can improve serum CRP, triglycerides, and glucose concentrations in patients with T2DM and hypertriglyceridemia., (© 2024 John Wiley & Sons Ltd.)

Background: Migraine is one of the most debilitating neurological disorders that causes frequent attacks of headaches and affects approximately 11% of the global population. Deficient or even insufficient levels of vital nutrients would increase the severity and frequency of migraine attacks. Therefore, we aimed to examine the practical supplements for the prevention and management of migraine attacks., Method: This narrative review study was conducted by searching PubMed, ISI web of science, EMBASE, Google Scholar, and Scopus using the keywords of "dietary supplement" and "migraine" plus their MeSH terms. Original articles published in English language from their inception to July 27th, 2024, studies that investigated adult population (aged >18 years), and those assessing the impact of intended nutrient supplementation on clinical symptoms of migraine were included in the study., Result: Oxidative stress and low intake of antioxidants would be risk factors for migraine attacks by inducing inflammation. The secretion of inflammatory cytokines, such as tumor necrosis factor (TNF)-a, would lead to neuroinflammation and migraine episodes by increasing the cellular permeability and interactions. Evidence also indicated a direct association between phases of migraine attacks and calcitonin gene-related peptide (CGRP), mitochondrial disorders, monoaminergic pathway, disruption in brain energy metabolism, and higher serum levels of glutamate and homocysteine. Therefore, supplementation with nutrients involved in mitochondrial function, brain energy metabolism, and even methyl donors would relieve migraine attacks., Conclusion: Evidence indicated that supplementation with riboflavin, omega-3 fatty acids, alpha lipoic acid, magnesium, probiotics, coenzyme Q10, ginger, and caffeine would have favorable effects on migraine patients. However, more prospective studies are required to evaluate the effect of other nutrients on migraine patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Hajhashemy, Golpour-Hamedani, Eshaghian, Sadeghi, Khorvash and Askari.)

This study evaluate the effect of succinylation of sodium alginate (ALG) by octenyl succinic anhydride (OSA) and its effect on the bergamot essential oil (BEO)-loaded ALG beads. The physico-chemical, antioxidant, antibacterial, and in vitro release properties of BEO-loaded ALG beads were assessed. The presence of BEO in alginate beads was assessd using Fourier transform-infrared (FT-IR) spectroscopy, X-ray diffraction (XRD), and differential scanning calorimetry (DSC) experiments. The higher amount of BEO in modified alginate beads at higher degree of substitution (DS) has been confirmed. Accordingly, it was discovered that the DS has notable effects on encapsulation efficiency (EE), loading capacity (LC) of beads, so that the values of EE and LC were about 31-75 % and 19-45 %, respectively, when the DS value of ALG was 0.00-0.022. Besides, BEO-loaded beads prepared using high DS, exhibited higher total phenolic compound (TPC = 21.101 mg garlic acid/g brad), good antioxidant activity (DPPH radical scavenging activity ≈ 69 %) and antibacterial properties (against E. coli and S. aureus). In vitro release analysis showed the initial fast release followed by a slow-release. OSA modification slowed down the release rate of bergamot essential oil from alginate beads. Also, the release of BEO from the beads followed Fickian diffusion., Competing Interests: Declaration of competing interest On behalf of all the authors I confirm that:, (Copyright © 2024 Elsevier B.V. All rights reserved.)

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).)

Several studies reported the benefits of flaxseed on inflammatory biomarkers, while others reported conflicting findings. Thus, the aim of this meta-analysis was to assess the impacts of flaxseed on inflammatory biomarkers in adults. Databases including Embase, PubMed, Scopus, and Web of Sciences were searched till February 2024. The 54 RCTs were included in the final analysis, which involved 3000 individuals from 12 countries. Overall, the flaxseed supplementation had a significant reduction in C-reactive protein (CRP) (SMD = -0.46; 95 % CI: -0.70, -0.23, P < 0.001; I 2 = 82.9 %, P < 0.001), and interleukin 6 (IL-6) (SMD = -0.64, 95 % CI: -1.13, -0.16, P = 0.010; I 2 = 92.7, P < 0.001). Furthermore, flaxseed did not significantly change the concentration of tumor necrosis factor α (TNF-α) (SMD = -0.17; 95 % CI: -0.63, 0.29, P = 0.467; I 2 = 92, P < 0.001). Flaxseed supplementation significantly decreased serum concentrations of CRP and IL-6, but not TNF-a. Thus, this meta-analysis suggests that the current evidence supports the potential benefits of flaxseed in managing inflammatory conditions., Competing Interests: Declaration of Competing Interest No conflict of interest to declare, (Copyright © 2024 Elsevier Inc. All rights reserved.)

Migraine is a complex neurovascular disorder characterized by recurrent headache attacks that are often accompanied by symptoms such as vomiting, nausea, and sensitivity to sound or light. Preventing migraine attacks is highly important. Recent research has indicated that alterations in gut microbiota may influence the underlying mechanisms of migraines. This study aimed to investigate the effects of inulin supplementation on migraine headache characteristics, quality of life (QOL), and mental health symptoms in women with migraines. In a randomized double-blind placebo-controlled trial, 80 women with migraines aged 20 to 50 years were randomly assigned to receive 10 g day -1 of inulin or a placebo supplement for 12 weeks. Severity, frequency, and duration of migraine attacks, as well as depression, anxiety, stress, QOL, and headache impact test (HIT-6) scores, were examined at the start of the study and after 12 weeks of intervention. In this study, the primary outcome focused on the frequency of headache attacks, while secondary outcomes encompassed the duration and severity of headache attacks, QOL, and mental health. There was a significant reduction in severity (-1.95 vs. -0.84, P = 0.004), duration (-6.95 vs. -2.05, P = 0.023), frequency (-2.09 vs. -0.37, P < 0.001), and HIT-6 score (-10.30 vs. -6.52, P < 0.023) in the inulin group compared with the control. Inulin supplementation improved mental health symptoms, including depression (-4.47 vs. -1.45, P < 0.001), anxiety (-4.37 vs. -0.70, P < 0.001), and stress (-4.40 vs. -1.50, P < 0.001). However, no significant difference was observed between the two groups regarding changes in QOL score. This study provides evidence supporting the beneficial effects of inulin supplement on migraine symptoms and mental health status in women with migraines. Further studies are necessary to confirm these findings. Trial registration: Iranian Registry of Clinical Trials (https://www.irct.ir) (ID: IRCT20121216011763N58).

Background: Hemodialysis (HD) patients have a low quality of life (QOL), and dietary intakes may impact both somatic and psychosocial aspects of QOL. Nevertheless, the relationship between QOL and different dietary fats has not yet been evaluated., Objective: The purpose of this study was to assess the association between QOL and the types/quantities of dietary fats intake in HD patients., Methods: In this multi-center cross-sectional study, 251 adult patients under dialysis for at least 3 months were included. Participants' dietary intakes were collected using a validated 168-item semi-quantitative FFQ during the past year. Moreover, to assess QOL, Kidney Disease Quality of Life Short Form (KDQOL-SF 1/3) was used. The linear regression between QOL and different types of dietary fats was conducted. p  < 0.05 was statistically significant., Results: Overall, 66 women and 185 men participated in our study. Regression analysis adjusted for total calorie intake showed that there was a negative association between QOL and total fat (95% CI: -0.187, -0.043), SFA (95% CI: -0.688, -0.143), MUFA (95% CI: -0.389, -0.065) and PUFA (95% CI: -0.401, -0.056) when types of dietary fats were individually included to the regression analysis. When all types of dietary fats were simultaneously entered into the analysis, the association between QOL and MUFA (95% CI: -0.243, 1.031) and PUFA (95% CI: -1.159, 0.084) were attenuated. The regression coefficient for SFA remained significant (95% CI: -0.968, -0.138). Also, there was a marginally significant association between SFA and the risk of low QOL was observed when all types of dietary fats were simultaneously entered into the analysis (OR = 1.051, 95% CI: 0.998-1.104)., Conclusion: Our investigation found a negative association between SFA consumption and QOL among different types of dietary fats. Furthermore, SFA mediated the relationship between QOL, MUFA, PUFA, and total fat. So, modification of dietary fat intake could enhance QOL in HD patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Navab, Foshati, Vajdi, Askari, Moeinzadeh, Heshamtipour, Mirzaeian and Rouhani.)

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).)

Objective: The observed impacts of Garcinia cambogia (GC) on serum leptin indicate inconsistency. We performed a systematic review and meta-analysis on randomized controlled trials (RCTs) to evaluate the effectiveness of GC on leptin levels., Methods: A thorough literature search was carried out using different online databases, including Scopus, Web of Science, PubMed, and Google Scholar, until May 25, 2024. Using random effects, weighted mean differences (WMDs) and corresponding 95 % confidence intervals (CIs) were computed. Standard procedures were followed to account for publication bias, study quality, and statistical heterogeneity., Results: In this meta-analysis, a total of eight eligible trials with 330 participants were ultimately included. Quality assessment showed that half of the included trials were considered to have fair quality, while the other half were deemed to have poor quality. Our analysis, with no indication of publication bias, showed a significantly decreased effect of GC on leptin compared with the placebo (WMD: -5.01 ng/ml; 95 % CI: -9.22 to -0.80, p = 0.02). However, significant heterogeneity was detected between studies (I 2 =93.5 %, p < 0.001). The Hartung-Knapp adjustment did not affect our results. Subgroup analysis revealed that GC consumption represents the most effects in trials with sample size ≥ 50 (WMD: -3.63 ng/ml; 95 % CI [-5.51, -1.76], p < 0.001), and mean age of participants ≥ 30 years (WMD: -7.43 ng/ml; 95 % CI [-9.31, -5.56], p < 0.001)., Conclusions: The findings of the present study showed that leptin levels might decline following GC administration., Registration Number: CRD42023486370., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Numerous clinical trials have investigated the effects of fenugreek, a traditional herbal medicine, on type 2 diabetes mellitus (T2DM). However, the results from these studies have been inconsistent. Therefore, we aimed to perform a meta-analysis on the effects of fenugreek supplementation on weight, body mass index (BMI), lipid profile, and glycemic indices in patients with T2DM., Methods: We searched PubMed, Scopus, Embase, ISI Web of Science, and Cochrane Library databases to identify clinical trial studies until October 2023. The data were analyzed using a random-effects model and presented as the weighted mean difference (WMD) along with the associated 95 % confidence interval (CI)., Results: A total of 19 studies were included in the meta-analysis. The results indicated a significant impact of fenugreek supplementation on lowering fasting plasma glucose (FPG) (WMD: 20.32 mg/dl; 95 % CI: 26.65 to -13.99), hemoglobin A1C (HbA1c) (WMD: 0.54 %; 95 % CI: 0.80 to -0.28), homeostatic model assessment of insulin resistance (HOMA-IR) (WMD: 0.36; 95 % CI: 0.67 to -0.05), total cholesterol (TC) (WMD: 33.10 mg/dL; 95 % CI: 64.31 to -1.88), low-density lipoprotein cholesterol (LDL-C) (WMD: 29.14 mg/dL; 95 % CI: 55.45 to -2.83), BMI (WMD: 0.73 kg/m2; 95 % CI: 1.40 to -0.07), and increasing the high-density lipoprotein cholesterol (HDL-C) (WMD: 5.68 mg/dL; 95 % CI: 3.51 to 7.85). However, the effect on fasting insulin, triglycerides, and weight was not significant., Conclusions: Fenugreek supplementation has been shown to improve FPG, HbA1C, HOMA-IR, TC, LDL-C, HDL-C, and BMI in patients with T2DM. The overall results suggest that fenugreek may have protective and therapeutic effects on T2DM parameters., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

The implementation of human research involving children and adolescents necessitates a nuanced understanding of the distinct ethical complexities and sensitivities that arise. This study aimed to conduct a comprehensive review of ethical guidelines for research with these populations by extensively examining existing standards and applied studies. The review revealed a myriad of challenges inherent in the involvement of children and adolescents as research subjects. The most important ethical challenges relate to the principles of bioethics and their compliance with human studies involving children/adolescents, informed consent, and risk assessment in studies on children/adolescents. To facilitate appropriate participation of youth in research endeavors, meticulous planning is required, in conjunction with a re-examination of the definitions of ethical principles in pediatric research, close monitoring of potential risks and benefits, and the utilization of a combination of innovative and traditional approaches to obtain informed consent that adheres to ethical standards. Performing research with children and adolescents requires special considerations to address the unique ethical issues that can emerge. By adhering to ethical guidelines tailored specifically to these vulnerable populations, researchers can help ensure that studies are conducted in an appropriate and responsible manner., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Journal of Research in Medical Sciences.)

Background: Coronary artery bypass graft (CABG) is one of the preferred treatments for patients with heart problems, especially in individuals with other comorbidities and when multiple arteries are narrowed. This study aimed to assess the effects of administrating curcumin-piperine on patients who underwent CABG surgery., Methods: This was a randomized, double-blind, placebo-controlled clinical trial, in which 80 eligible adults who underwent CABG surgery, were randomized into 4 groups. Patients received 3 tablets daily for 5 days after the surgery, which contained curcumin-piperine (each tablet contained 500 mg curcumin +5 mg piperine) or a placebo (each tablet contained 505 mg maltodextrin). Group A received 3 placebo tablets, group B received 2 placebos and one curcumin-piperine tablet, group C received 1 placebo and 2 curcumin-piperine tablets, and group D received 3 curcumin-piperine tablets. Before and after the intervention, C-reactive protein (CRP), total antioxidant capacity (TAC), cardiometabolic factors, clinical outcomes, and 28-day mortality were evaluated., Results: Between-group analysis showed that CRP significantly decreased (P = 0.028), and TAC significantly increased (P = 0.033) after the intervention (Post hoc analysis showed that for CRP, the difference was between group B and D, and for TAC was between group C and D). Between-group analysis also showed that creatine kinase mono-phosphate (CK-MB) marginally reduced (P = 0.077); however, changes for troponin I (P = 0.692), lactate dehydrogenase (LDH) (P = 0.668), ejection fraction (P = 0.340), and arterial fibrillation (P = 0.99) were not significant. Blood urea nitrogen (P = 0.820) and serum creatinine (P = 0.244) did not show notable changes between groups., Conclusion: Supplementation with curcumin-piperine had a promising effect on serum CRP and TAC. It also had a favorable impact on CK-MB among patients who underwent CABG surgery., Trial Registration: IRCT20201129049534N4, available on https://en.irct.ir/trial/56930., Competing Interests: Declaration of competing interest Muhammed Majeed was the founder of the Sabinsa Corporation and Sami- Sabinsa Group Limited., (Copyright © 2024 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to test our hypothesis that herbal tea may improve anthropometric parameters, metabolic factors, and hormone levels in women with polycystic ovarian syndrome (PCOS). A literature search was conducted on Information Sciences Institute, Medline (PubMed), Scopus, Embase, and Google Scholar, up to March 2023 without applying language or date restrictions. RCTs that assigned herbal tea vs. placebo on PCOS women and evaluated changes in anthropometric measurements, metabolic indices, or hormonal profiles were included. Six RCTs with 235 PCOS women (119 in the intervention and 116 in the control group) were included. Meta-analysis showed that herbal tea consumption led to significant decreases in weight (weighted mean difference [WMD], -2.02 kg; 95% confidence interval [CI], -3.25, -0.80), body mass index (BMI) (WMD, -0.88 kg/m 2 ; 95% CI, -1.47, -0.28) and fasting blood glucose (FBG) (WMD, -6.47 mg/dL; 95% CI, -8.49, -4.45), compared to the control group. Herbal tea supplementation has also significantly increased follicle-stimulating hormone (FSH) concentration (WMD, 0.56 IU/L; 95% CI, 0.17, 0.95). Meanwhile, the effect of herbal tea on the waist/hip ratio, hip circumference, waist circumference, body fat, fasting insulin, FBG/insulin ratio, luteinizing hormone, total testosterone, and dehydroepiandrosterone sulfate was not significant. Herbal tea might be a potential supplemental therapy to manage weight, BMI, FBG, and FSH in PCOS women. Further large randomized clinical trials are recommended to affirm these findings., Competing Interests: Conflict of Interest: The authors declare that they have no competing interests., (Copyright © 2024. The Korean Society of Clinical Nutrition.)

Introduction and Aim: Research on the effects of propolis consumption on body composition, and blood pressure (BP) has produced inconsistent results. This systematic review and dose-response meta-analysis was carried out to compile the data from the randomized controlled trials (RCTs) on how propolis supplementation affects body composition, and BP level in adults., Materials and Methods: A systematic literature search was conducted using electronic databases, including PubMed, Embase, Scopus, Web of Science, and Cochrane library, up to January 2024. The RCTs, evaluating the effects of propolis consumption on weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), fat mass (FM), systolic BP (SBP), and diastolic BP (DBP), were included in the study. We used the random-effects model to establish the pooled effect size., Results: A total of 22 RCTs involving 1082 participants were included in the study. Propolis supplementation demonstrated significant reductions in weight (weighted mean difference [WMD]: -0.37 kg; 95% confidence interval [CI]: -0.63 to -0.12), and BMI (WMD: -0.11 kg/m 2 ; 95% CI: -0.13 to -0.09). However, there were no significant effects on WC, WHR, FM, HC, SBP, and DBP levels. The dose-response analysis revealed a significant nonlinear relationship between propolis dosage and WC ( P  = 0.020). Moreover, the BMI ( P  = 0.047) and WC ( P  = 0.004) reduction trend continues until 8 weeks of intervention and then this impact plateaued., Conclusions: Supplementation with propolis seems to be effective in reducing weight and BMI. However, it should be noted that the anti-obesity properties of propolis supplementation were small and may not reach clinical importance. Therefore, future well-designed studies with a large sample size are needed to investigate the effect of propolis on body composition and BP in adults., Competing Interests: The authors declare that there are no conflicts of interest., (© 2024 The Author(s).)

Diminished ovarian reserve (DOR) is associated with reduced fertility and poor reproductive outcomes. The association between dietary patterns and DOR was not well studied. The purpose of this study was to evaluate the relationship between adhering to the healthy eating index (HEI-2015) and the risk of DOR. In this case-control study, 370 Iranian women (120 with DOR and 250 age- and BMI-matched controls) were examined. A reliable semi-quantitative food frequency questionnaire was used to collect diet-related data. We analyzed the HEI-2015 and their dietary intake data to determine major dietary patterns. The multivariable logistic regression was used in order to analyze the association between HEI-2015 and risk of DOR. We found no significant association between HEI-2015 score and risk of DOR in the unadjusted model (OR 0.78; 95%CI 0.59, 1.03). After controlling for physical activity and energy intake, we observed that women in the highest quartile of the HEI-2015 score had 31% decreased odds of DOR (OR 0.69; 95%CI 0.46, 0.93). This association remained significant even after adjusting for all potential confounders. Overall, increased adherence to HEI may lead to a significant reduction in the odds ratio of DOR. Clinical trials and prospective studies are needed to confirm this association., (© 2024. The Author(s).)

Scope: The present study aims to assess the interaction of dietary patterns (DPs) and paraoxonase1 (PON1) rs662 polymorphism on coronary artery disease (CAD) severity and its risk factors., Methods and Results: This cross-sectional study is conducted on 425 patients undergoing angiography. The PON1 genotypes are detected by the polymerase chain reaction-restriction fragment length polymorphism (RFLP-PCR) technique. DPs are extracted by exploratory factor analysis. Two dietary patterns Western (WDP) and Traditional (TDP) are extracted. A gene-diet interaction concerning a high Gensini score is observed. Accordingly, high adherence to the WDP increases the odds of a high Gensini score in R allele carriers compared to QQ genotype carriers by 2.48 times (odds ratio [OR]: 2.48, 95% confidence interval [CI] 0.98-6.26, p = 0.05). Also, the risk of high systolic blood pressure (SBP) is higher in R allele carriers with high adherence to the WDP compared to QQ genotype carriers (OR: 3.49, 95% CI 1.38-8.82, p < 0.001. No significant interaction is observed between TDP and PON1 rs662 on any cardiometabolic risk factors (p-value > 0.05). The results remain significant after adjusting for confounders., Conclusion: The present study's findings indicate the existence of an interaction between the PON1 rs662 polymorphism and the WDP on the risk of stenosis severity and high SBP., (© 2024 Wiley‐VCH GmbH.)

Aims: We evaluated associations between diet quality and migraine outcomes., Methods: The current work represented a cross-sectional study on 262 patients with migraine (20-50 y). Diet quality was assessed using the standard healthy eating index 2015 (HEI-2015) and alternative healthy eating index 2010 (AHEI-2010). A validated 168-item food frequency questionnaire was used to assess dietary intake. Migraine outcomes included clinical factors (severity, duration, frequency, and disability related to migraine) and serum nitric oxide (NO). Associations between diet quality indices and migraine outcomes were evaluated using linear regressions, and β and 95% corresponding confidence interval (CI) were reported., Results: HEI-2015 was inversely associated with migraine frequency ( β  = -4.75, 95% CI: -6.73, -2.76) in patients with the highest HEI scores (third tertile) vs. those with the lowest scores (first tertile) after adjusting for relevant confounders. AHEI-2010 was inversely associated with migraine frequency ( β  = -3.67, 95% CI: -5.65, -1.69) and migraine-related disability ( β  = -2.74, 95% CI: -4.79, -0.68) in adjusted models. Also, AHEI-2010 was inversely associated with migraine severity in patients in the second vs. first tertile ( β  = -0.56; 95% CI: -1.08, -0.05). We detected no associations between diet quality and NO levels (All P  > 0.14)., Conclusions: Improved diet quality may be associated with favorable migraine outcomes (lower headache frequency, severity, and migraine-related disability). Future studies are required to confirm and delineate the causal mechanisms of our observations.

Context: Although several investigations have been conducted on the association between serum vitamin D levels and prediabetes and type 2 diabetes mellitus (T2DM) in children and adolescents, their findings are inconsistent., Objective: We conducted a systematic review and dose-response meta-analysis to summarize this subject., Data Sources: The electronic databases of ISI Web of Science, Scopus, PubMed, and motor engineering of Google Scholar were comprehensively searched up to May 2023., Data Extraction: Epidemiologic studies that investigated the risk of hyperglycemia and insulin resistance in relation to serum 25-hydroxy vitamin D levels in children and adolescents were included., Data Analysis: Twenty-two investigations, with a total of 38 622 participants, were systematically reviewed. Meta-analysis of 15 studies (n = 32 720 participants) showed that participants with the highest serum vitamin D levels had 42% lower risk of hyperglycemia, compared with those in the lowest category of serum vitamin D levels (relative risk [RR] = 0.58; 95%CI, 0.48, 0.71). Moreover, pooling 8 studies (n = 10 465 participants) illustrated that highest serum vitamin D level was associated with a 44% lower risk of insulin resistance compared with the lowest serum vitamin D level (RR = 0.56; 95%CI, 0.37, 0.83). Based on linear dose-response analysis, each 10 nmol/L increment in serum 25-hydroxy vitamin D was associated with a 6% decreased risk of hyperglycemia and insulin resistance in children. Furthermore, nonlinear dose-response analysis revealed that increasing serum vitamin D concentration from 40 nmol/L to sufficient values (>50 nmol/L) was associated with a decreasing trend in risk of hyperglycemia and insulin resistance., Conclusion: This meta-analysis revealed inverse associations between serum vitamin D levels and hyperglycemia and insulin resistance in children and adolescents, in a dose-response manner. Increasing serum vitamin D concentration from 40 nmol/L to sufficient values (>50 nmol/L) was associated with a decreasing trend in hyperglycemia and insulin resistance risk. Systematic Review Registration: PROSPERO registration no. CRD42023458155., (© The Author(s) 2024. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: The effects of jujube (Ziziphus jujube) consumption on metabolic and mental health outcomes in subjects diagnosed with metabolic syndrome (MetS) is unknown and remains to be examined. Hence, we carried out a parallel-group, randomized controlled trial to investigate this issue., Methods: Eligible participants were randomly assigned to the intervention (n = 30) or the control (n = 30) groups to receive either jujube or a placebo for eight weeks. Subjects were provided with 30 g dried jujube powder or placebo and were asked to consume half of the powder at 10 a.m. and the rest at 4 p.m. Lipid profile, fasting blood glucose (FBG), waist circumference (WC), and blood pressure were evaluated as primary outcomes. Secondary outcomes collected were mental health measures (e.g., depression, anxiety, and stress)., Results: Jujube consumption failed to decrease FBG, total cholesterol, low-density lipoprotein cholesterol, and blood pressure, as well as depression and anxiety scores (P > 0.05). However, the between-group comparison revealed a significant improvement in WC (- 3.98 vs. - 0.51, P = 0.01), triglyceride (TG) (- 24.96 vs. - 0.73, P = 0.03), and high-density lipoprotein cholesterol (HDL-C) (2.83 vs. 0.40, P = 0.01) in the jujube group compared to the placebo. In addition, compared to the control group, jujube consumption led to a significant improvement in the score of stress (- 5.80 vs. - 2.86, P = 0.01)., Conclusion: Jujube consumption only had beneficial effects on WC, TG, and HDL-C in subjects with MetS. However, the current study has methodological weaknesses in blinding and herb purity/potency testing, which should be addressed in future studies., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Previous studies have assessed how supplementing with policosanol affects blood sugar levels. The outcomes, nevertheless, were not constant. Multiple electronic databases were searched including ISI Web of Science, Cochrane Library, PubMed, Google Scholar, and Scopus until February 9, 2023. To assess the effects of policosanol on glucose, we employed a random-effects or fixed-effects meta-analysis approach to examine the weighted mean differences (WMDs) and associated 95 % confidence intervals (CI) before and after policosanol and placebo administration. The final analysis comprised a total of 25 trials with 2680 participants. Compared to the control group, policosanol supplementation significantly reduced blood glucose levels (WMD: -2.24 mg/dl; 95 % CI: -4.05, -0.42, P = 0.01). Findings from subgroup analysis revealed a significant reduction of policosanol supplementation on glucose levels in period of less than 24 weeks, and in individuals below 50 years of age. Additionally, the reduction was statistically significant in dosage of 10 mg/day. Our dose-response analysis indicates no evidence of a non-linear relationship between policosanol dose and duration and changes in glucose levels (P-nonlinearity = 0.52, and P-nonlinearity = 0.52, respectively). Policosanol supplementation might improve blood glucose. Further trials with more complex designs are required to confirm the findings., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Context: The relation of magnesium (Mg) intake with depression was previously investigated by meta-analyses. However, due to limited data, a dose-response analysis was not performed., Objective: Considering the recently published articles, a systematic review and dose-response meta-analysis was conducted to summarize the relation of dietary Mg intake with depression in adults., Data Sources: Medline (PubMed), ISI Web of Science, Scopus, and Google Scholar were comprehensively searched up to August 2023., Data Extraction: Observational studies that reported the relation of dietary Mg intake and depression in adults were included and their data were extracted., Data Analysis: A total of 63 214 participants from 10 cross-sectional and 3 cohort studies were included in the current study. Pooling 15 effect sizes from 12 studies (including 50 275 participants) revealed that individuals with the highest Mg intake had a 34% lower risk of depression, compared with those with the lowest Mg intake (RR: 0.66; 95% CI: 0.57, 0.78). Moreover, the linear dose-response analysis revealed that each 100-mg/d increment in Mg intake was associated with a 7% reduced risk of depression (RR: 0.93; 95% CI: 0.90, 0.96). Additionally, based on nonlinear dose-response analysis, increasing Mg intake from 170 to 370 mg/d was associated with a reduced risk of depression. Analyses were also conducted on 9 studies (49 558 participants) with representative populations, and similar results were found in the meta-analysis (RR: 0.71; 95% CI: 0.61, 0.83) and linear (RR: 0.93; 95% CI: 0.90, 0.96) and nonlinear dose-response analysis., Conclusion: The current study shows an inverse dose-dependent association between dietary Mg intakes and risk of depression in both a general and representative population of adults in a dose-response manner., Systematic Review Registration: PROSPERO registration no. CRD42024506570., (© The Author(s) 2024. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aim: The present double-blinded randomized clinical trial aimed to investigate the effect of selenium supplementation on oxidative stress, clinical, and physiological symptoms in patients with migraine., Methods: In total, 72 patients with migraine were randomly assigned to receive either 200 μg/day selenium ( n  = 36) or placebo ( n  = 36) for 12 weeks. Clinical traits of migraine (e.g., severity, frequency, and duration of headaches), mental health indices (e.g., depression, anxiety, and distress), quality of life, biomarkers of oxidative stress (e.g., nitric oxide [NO], malondialdehyde [MDA], total antioxidant capacity [TAC], total oxidant status [TOS]), and anthropometric indices were assessed at baseline and at the end of the study., Results: Selenium supplementation resulted in a significant reduction in NO (-1.24 ± 0.43 vs. 0.16 ± 0.43; p  = 0.03) levels and a significant increase in TAC (9.89 ± 2.50 vs. -0.18 ± 2.50; p  = 0.01) compared to the placebo group. Moreover, selenium supplementation had a significant protective effect against MDA levels compared to placebo (0.33 ± 0.57 vs. 1.83 ± 0.57; p  = 0.03). In addition, selenium intake was associated with a lower headache frequency (-8.15 ± 0.77 vs. -4.12 ± 0.77; p  < 0.001) and severity (-2.89 ± 0.42 vs. -1.16 ± 0.42; p  = 0.01) as well as a lower Headache Impact Test-6 (HIT-6) score (-9.22 ± 2.00 vs. -2.08 ± 2.00; p  = 0.02) compared to the controls. For other outcome variables, we found no significant effect., Conclusion: Selenium supplement may be considered a complementary therapy in patients with migraine due to its beneficial effects on oxidative stress and migraine symptoms. Further studies are needed to affirm our findings. Clinical Trial Registration : This study was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir) on 27 May 2023 with code number of IRCT20121216011763N60., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Balali, Sadeghi, Khorvash, Rouhani and Askari.)

The fabrication possibility of nanocomposite film from sweet cherry tree exudate gum (SCG) was studied. To improve SCG film properties, oxidation with hydrogen peroxide, ultraviolet irradiation (UV-A and UV-C), and TiO 2 nanoparticles (T-NPs) were used. Hydrogen peroxide oxidation at higher amounts decreased the water vapor permeability (WVP) and thickness and increased the mechanical properties and transparency. In comparison with the UV-A, UV irradiation of the C-type increased permeability, and elongation at break (EAB) and thickness, but reduced the tensile strength (TS), solubility, and transparency. The permeability and tensile strength were increased and elongation at break was decreased at a longer time of irradiation. The transparency values of fabricated films ranged from 65.3 to 79.5 % and WVP were in the range of 2.32-4.72 (×10 -10  g/m.s.Pa). The measured TS of the SCG films were between 2.2 and 5 MPa and the EAB of the SCG films was between 35 and 68.7 %. The FTIR spectrum and SEM images revealed that the treatments could affect the bonds and the smoothness of the film surface, respectively. Images provided by AFM showed that the roughness of the films was increased by the addition of T-NPs. The incorporation of T-NPs increased the TS and decreased EAB and WVP. These results indicated that oxidation, UV irradiation and nanomaterials incorporation could be used to improve SCG film properties that are related to food packaging material., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Context: Several studies have investigated the relationship between serum vitamin D and dyslipidemia in children and adolescents, but the findings have been contradictory., Objective: The current systematic review and dose-response meta-analysis investigated the serum vitamin D - dyslipidemia relationship in children and adolescents., Data Sources: ISI Web of Science, Scopus, MEDLINE (PubMed), EMBASE databases, and Google Scholar, were searched up to December 2022., Data Extraction: Observational studies that investigated the odds of dyslipidemia in categories of serum vitamin D levels in children were included, and their data were extracted., Data Analysis: Pooling of 17 effect sizes from 15 studies (39 342 participants) showed that subjects with higher serum vitamin D had 27% lower odds of hypertriglyceridemia (odds ratio [OR] = 0.73; 95% confidence interval [CI]: 0.60, 0.88). A meta-analysis of 18 effect sizes from 16 studies (39 718 participants) illustrated that highest vs lowest serum vitamin D was related to 22% lower odds of low high-density lipoprotein cholesterol (HDL-c) (OR = 0.78; 95% CI: 0.66, 0.91). Also, a nonlinear association between serum vitamin D and odds of abnormal lipid profile was found: elevating values of 25-hydroxyvitamin D from 35 nmol/L to 55 nmol/L was associated with a decreasing trend in odds of hypertriglyceridemia, hyper low-density lipoprotein cholesterolemia, hypercholesterolemia, and hypo HDL-cholesterolemia. However, no significant linear association was observed. Based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE), the certainty of all evidence was rated as high., Conclusion: This meta-analysis revealed that the level of 25-hydroxyvitamin D was inversely related to odds of abnormal serum triglycerides and HDL-c in children and adolescents. Increasing serum vitamin D from 35 nmol/L to 55 nmol/L was associated with a decreasing trend in the odds of abnormal serum triglycerides, HDL-c, low-density lipoprotein cholesterol, and total cholesterol in children., Systematic Review Registration: PROSPERO registration no. 42023400787., (© The Author(s) 2024. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aims: The aim of this study was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the impact of sesame supplementation on body weight (BW), body mass index (BMI), triglycerides (TGs), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), and high-density lipoprotein-cholesterol (HDL-C) in patients with type 2 diabetes mellitus (T2DM)., Data Synthesis: PubMed, Scopus, ISI Web of Science, and Embase were searched without any restrictions until September 2023.Only RCTs reporting the effects of sesame supplementation on body composition and lipid profiles were included, while observational studies and animal models were excluded. The methodological quality of the studies was assessed using the Cochrane risk of bias tool. Out of 997 studies identified, 10 were included in the systematic review and meta-analysis. Our meta-analysis suggested a significant association between sesame supplementation and reduction in TG (weighted mean difference (WMD): -37.61 mg/dl, 95 % CI: -61.48, 13.73), TC (WMD: -32.69 mg/dl, 95 % CI: -47.26, 18.12), and LDL-C (WMD: -28.72 mg/dl, 95 % CI: -44.68, 12.76). However, our meta-analysis indicated that the supplementary intake of sesame had no significant effect on HDL-C, BW, and BMI in patients with T2DM., Conclusions: This study showed that sesame consumption significantly lowered TG, TC, and LDL-C levels, which may have contributed to the improvement of clinical symptoms in T2DM. However, given the limited number of trials included in the analysis, additional large-scale studies are needed to confirm the effects of sesame consumption on the lipid profile and body composition in patients with T2DM., Prospero Code: CRD42023460630., Competing Interests: Declaration of competing interest The authors declare that there are no conflicts of interest., (Copyright © 2024 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

The COVID-19 pandemic that started in 2019 and resulted in significant morbidity and mortality continues to be a significant global health challenge, characterized by inflammation, oxidative stress, and immune system dysfunction.. Developing therapies for preventing or treating COVID-19 remains an important goal for pharmacology and drug development research. Polyphenols are effective against various viral infections and can be extracted and isolated from plants without losing their therapeutic potential. Researchers have developed methods for separating and isolating polyphenols from complex matrices. Polyphenols are effective in treating common viral infections, including COVID-19, and can also boost immunity. Polyphenolic-based antiviral medications can mitigate SARS-CoV-2 enzymes vital to virus replication and infection. Individual polyphenolic triterpenoids, flavonoids, anthraquinonoids, and tannins may also inhibit the SARS-CoV-2 protease. Polyphenol pharmacophore structures identified to date can explain their action and lead to the design of novel anti-COVID-19 compounds. Polyphenol-containing mixtures offer the advantages of a well-recognized safety profile with few known severe side effects. However, studies to date are limited, and further animal studies and randomized controlled trials are needed in future studies. The purpose of this study was to review and present the latest findings on the therapeutic impact of plant-derived polyphenols on COVID-19 infection and its complications. Exploring alternative approaches to traditional therapies could aid in developing novel drugs and remedies against coronavirus infection., (© 2024. The Author(s) under exclusive licence to Maj Institute of Pharmacology Polish Academy of Sciences.)

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).)

We investigated the relationship between dietary phytochemical index (DPI) and migraine headaches in Iranian patients, analyzing both clinical and psychological traits. A cross-sectional study was conducted using non-obese adults aged 20-50 years who were diagnosed with migraine. The study used a validated 168-item food frequency questionnaire to assess the usual dietary intake of participants. The DPI was calculated using the following formula: [daily energy derived from phytochemical-rich foods (in kJ)/total daily energy intake (in kJ)] × 100. Clinical outcomes of migraine including frequency, duration, and severity of headaches, as well as migraine-related disability were obtained using relevant questionnaires. Moreover, the mental health profile of patients including depression, anxiety, and stress, as well as serum levels of nitric oxide (NO) were measured. A Poisson regression was used for headache frequency. Linear regression analyzed migraine-related outcomes including duration, severity, migraine-related disability, and serum NO levels. In addition, psychological traits were analyzed via logistic regression. A total of 262 individuals (85.5% females) with a mean age of 36.1 years were included in the analysis. The frequency of migraine attacks was lower in patients in the last DPI tertile compared to those in the first DPI tertile both in the crude [incidence rate ratio (IRR) = 0.70, 95% confidence interval (CI) 0.63, 0.78, P trend  < 0.001] and fully-adjusted models (IRR = 0.84, 95% CI 0.74, 0.96, P trend  = 0.009). After controlling for potential confounders, an inverse relationship was observed between higher adherence to DPI and migraine-related disability (β = - 2.48, 95% CI - 4.86, - 0.10, P trend = 0.046). After controlling for potential confounders, no significant relationship was observed between DPI and depression (OR = 0.79, 95% CI 0.42, 1.47, P trend  = 0.480), anxiety (OR = 1.14, 95% CI 0.61, 2.14, P trend  = 0.655), and stress (OR = 1.04, 95% CI 0.57, 1.90, P trend  = 0.876). Higher intakes of phytochemical-rich foods may be associated with lower migraine frequency and improved daily activities among patients. Further studies should confirm our observations and delineate the biological pathways linking phytochemicals and migraine headaches., (© 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).)

Objective: Policosanol is a mixture of long chain alcohols refined from sugar cane. Significant reductions in liver enzymes have been observed in some studies. However, the impact of policosanol on liver enzymes remained controversial. The current meta-analysis aims to evaluate the effect of policosanol supplementation on the levels of alanine transaminase (ALT) and aspartate transaminase (AST)., Methods: The literature was systematically searched for studies published up to November 2023 in PubMed/Medline, Google Scholar, EMBASE, and Scopus. Randomized controlled trial (RCT) studies were included to evaluate the intervention effect of policosanol compared to placebo on ALT and AST. DerSimonian and Laird models were used to calculate effect sizes., Results: Twenty-three trials including 2535 participants were included in the study. The combination of effect sizes, regarding the random-effects model, demonstrated significant changes in ALT serum levels after intervention (WMD: -1.48 U/L; 95% CI: -2.33 to -0.64; P = 0.001), and AST (WMD: -1.10 U/L; 95% CI: -1.70 to -0.51; P < 0.001). Subgroup analysis of AST and ALT showed that this reduction effect was most often observed at the dose of 20 mg/d. The dose-response analysis represented a non-significant non-linear connection between the dosage and duration of policosanol intervention in ALT and AST serum reduction., Conclusion: Policosanol supplementation exerts a beneficial effect on liver enzymes as well as ALT and AST concentrations in adults. However, further long-term and well-designed RCTs with better quality are needed to further assess and confirm these results., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Although previous studies investigated the relation of protein intake and gestational diabetes mellitus (GDM), their findings were controversial. Therefore, we aimed to summarize this association, through a comprehensive systematic review and dose-response meta-analysis., Methods: Electronic databases including MEDLINE (PubMed), ISI Web of Science, Scopus and motor engineering of Google Scholar were systematically searched up to April 2023. Observational studies which investigated odds of GDM in relation to protein intake were included., Results: A total of 31,005 participants with 3451 cases of GDM from 13 eligible investigations were included in the systematic review and meta-analysis. Comparing the highest and lowest intakes of total, animal, and plant proteins revealed the summary RRs of 1.82 (95% CI: 1.42, 2.33), 1.79 (95% CI: 1.50, 2.14), and 0.98 (95% CI: 0.81, 1.20), respectively, indicating a significant positive association between total and animal protein intake and GDM. In the dose-response analyses, each 5% increment in energy intake from total protein during pregnancy was related to 20% increased odds of GDM (RR = 1.20; 95% CI: 1.09, 1.33). In the non-linear dose-response analyses, we found a non-linear association for animal protein intake during pregnancy (P for non-linearity <0.001); so that, a risk increase was seen from zero to 10% of energy intake from animal proteins, however, a risk reduction was seen after 10% of energy intake. However, there was not any significant non-linear trend between plant protein intake during pregnancy and risk of GDM. Based on the GRADE assessment, the quality of evidence for total, animal and plant protein was rated as "moderate", "moderate" and "very low", respectively., Conclusion: We found a significant positive association between total protein intake and GDM; however, the associations of animal and plant protein intake with GDM were dose-dependent., Competing Interests: Conflicts of interest None of the authors had any personal or financial conflicts of interest., (Copyright © 2024 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)