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This systematic review aimed to gather data on the effects of sumac supplementation on lipid profile. A systematic literature search was carried out using electronic databases (PubMed, Scopus, and Web of Science) up to March 2023 to identify eligible randomized controlled trials (RCTs) assessing the effects of sumac intake on lipid profile as an outcome. All participants enrolled in our study were adult individuals who consumed sumac, in various forms, as an intervention. The included articles were assessed using the Cochrane risk of bias assessment tool. Heterogeneity tests of the selected trials were performed using the I2 statistic. Random effects models were assessed based on the heterogeneity tests, and pooled data were determined as the weighted mean difference with a 95% confidence interval. In total, seven RCTs with a total sample size of 570 subjects were included. This study found a significant decrease in total cholesterol (TC) (weighted mean difference [WMD]: -10.01 mg/dL; 95% CI: -18.67, -1.34), triglyceride (TG) (WMD: -8.52 mg/dL; 95% CI: -14.79, -2.25), and low-density lipoprotein (LDL)-C levels (WMD: -9.25 mg/dL; 95% CI: -14.56, -3.93); Moreover, a significant increase was observed in high-density lipoprotein (HDL)-C concentration (WMD: 2.97 mg/dL; 95% CI: 0.75, 5.19). The reduction in TG and TC was greater in studies with a duration of ≥12 compared to <12 weeks. The increase in HDL-C was greater in participants with an intervention duration of ≥12 compared to <12 weeks. Moreover, subgroup analysis based on the dose of sumac suggested a significant reduction in TC and LDL, specifically for doses below 3 g. Consumption of sumac significantly decreased serum TC, LDL-C, and TG concentrations. This study suggested significantly positive effects on HDL-C by intake of sumac. Longer interventions (>12 weeks) have a more favorable impact on TC, LDL-C, and HDL-C, while sumac doses below 3 g/day show greater effects on TC and LDL-C. These findings underscore the potential of sumac supplementation as a valuable approach to lipid profile management.
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Hiperlipidemias , Lipídeos , Extratos Vegetais , Rhus , Adulto , Humanos , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Suplementos Nutricionais , Lipídeos/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Rhus/química , Triglicerídeos , Extratos Vegetais/uso terapêutico , Hiperlipidemias/tratamento farmacológicoRESUMO
BACKGROUND AND AIMS: Neuregulin 4 (NRG4) and irisin are adipokines that have been suggested to be associated with cardiometabolic risk factors and coronary artery disease (CAD), but the data are inconclusive. This study aimed to investigate the relationship between circulating NRG4 and irisin and cardiometabolic risk factors with CAD risk and severity. METHODS AND RESULTS: In this cross-sectional study, the presence of CAD and the severity of stenosis (gensini score) were documented based on coronary angiography in 166 adults. Circulating NRG4 and irisin, glucose homeostasis markers, hs-CRP, lipid profiles, blood pressure, and anthropometric measurements were assessed as well. Age (p = 0.005), sex (p = 0.008), SBP (p = 0.033), DBP (p = 0.04), MAP (p = 0.018), FBG (p = 0.012), insulin (p = 0.039) and HOMA-IR (p = 0.01) were significantly associated with odds of having CAD. The final logistic regression model showed that age, sex, HOMA-IR, and MAP were the most important determinants of having CAD. There were no significant associations between circulating irisin and NRG4 with odds of having CAD. The final general linear model showed that being men (ß = 17.303, 95% CI: 7.086-27.52, P = 0.001), age (Aß = 0.712, 95% CI: 0.21-1.214, P = 0.006), HOMA-IR (Aß = 2.168, 95% CI: 0.256 to 4.079, P = 0.027), and NRG4 level (ß = 1.836, 95% CI: 0.119-3.553, P = 0.036) were directly associated with higher gensini score. Participants with the three-vessel disease had a mean increase of about 5 units in circulating irisin compared to those with no clinical CAD (ß = 5.221, 95% CI: 0.454-9.987, p = 0.032). CONCLUSIONS: This study showed that the adipokines NRG4 and Irisin might be associated with the severity of coronary stenosis.
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Doença da Artéria Coronariana , Neurregulinas , Adulto , Feminino , Humanos , Masculino , Adipocinas , Fatores de Risco Cardiometabólico , Doença da Artéria Coronariana/sangue , Estudos Transversais , Fibronectinas , Neurregulinas/sangueRESUMO
BACKGROUND: The goal of this study was to assess the anthropometric and biochemical parameters of children and adolescents with phenylketonuria (PKU). METHODS: The participants in this cross-sectional study ranged in age from four to 18 years old. Biochemical markers such as vitamin B12, folic acid, iron, ferritin, calcium, 25-hydroxy vitamin D3, zinc, plasma phenylalanine (Phe) and tyrosine (Tyr) levels in blood were evaluated, as well as demographics and anthropometric measurements. A three-day dietary recall questionnaire was completed by all individuals. RESULTS: 80% (64) of the 80 patients (42 females, 52.5%) had typical PKU. Consanguineous marriages were found in 57.5% (46) of the patients' parents. According to the height for age index, 17.5% of the study group (n = 14) were short or very short. According to age-related weight and body mass index (BMI), 37.5% (n = 30) and 43.8% (n = 35) of people are obese or overweight, respectively. Biochemical tests revealed increased vitamin B12 levels and 25-hydroxy vitamin D3 deficiency in 35% (n = 28) of the patients, insufficient folic acid in 12.5% (n = 10), and elevated phenylalanine levels in 70.3% (n = 45) of children under 12 years old, and adolescents 62.5% (n = 10). A high Phe intake (OR = 4.44, CI %95 = 1.27-15.57) is a risk factor for obesity and overweight. CONCLUSION: Patients with PKU had a high rate of overweight and obesity. PKU patients who are overweight or obese do not differ from normal-weight patients in terms of dietary intake or laboratory findings (except for serum iron levels). One-third of patients with phenylketonuria were vitamin D deficient and had a BMI/A index of overweight/obese. It is recommended to use special medical food to help solve energy and nutrient deficiencies.
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Fenilcetonúrias , Deficiência de Vitamina D , Criança , Feminino , Humanos , Adolescente , Pré-Escolar , Estado Nutricional , Sobrepeso/epidemiologia , Estudos Transversais , Obesidade , Vitamina B 12 , Deficiência de Vitamina D/epidemiologia , Ácido Fólico , Colecalciferol , Ferro , FenilalaninaRESUMO
PURPOSE: Carbohydrate intake and insulinemic potential of diet are suggested to be correlated with the development of different chronic diseases. Considering the limited research on obesity, this study aimed to investigate the association of dietary insulin index (DII), dietary insulin load (DIL), and low-carbohydrate diet score (LCDS) with body weight and obesity in healthy adults. METHODS: In this cross-sectional study, DII, DIL, and LCDS were calculated using relevant formulas based on dietary intakes obtained by a valid 168-item food frequency questionnaire, in 393 otherwise healthy adults of either normal-weight, overweight, or obese. RESULTS: Individuals in the highest tertile of DIL and DII had respectively 73% (OR: 0.27, 95% CI 0.08-0.94, p = 0.049) and 50% (OR: 0.5, 95% CI 0.26-0.96, p = 0.038) lower odds of being overweight compared to the lowest tertile, after adjusting the effects of age, sex, and dietary energy intake. Participants in the highest tertile of DIL had 92% greater odds of being obese compared to the lowest tertile, but this association did not remain significant after adjusting the effect of energy intake. Individuals in the highest tertile of LCDS had about 2 times odds of being overweight compared with those in the lowest tertile (OR: 2.04, 95% CI 1.04-4.01, p = 0.049). There was no relationship between being obese and tertiles of LCDS. CONCLUSION: Higher dietary carbohydrate intake and insulinemic potential of diet could not be considered independent dietary risk factors for overweight or obesity. LEVEL OF EVIDENCE: Level III: evidence obtained from an observational study.
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Insulina , Sobrepeso , Adulto , Humanos , Sobrepeso/complicações , Estudos Transversais , Obesidade/etiologia , Dieta com Restrição de CarboidratosRESUMO
Previous studies have reported that vitamin C supplementation may decrease lipid profile in patients with type 2 diabetes mellitus (T2DM). This systematic review and meta-analysis evaluated the influence of vitamin C supplementation on lipid profile in patients with T2DM. Studies examining the effects of vitamin C supplementation on lipid profile in patients with T2DM, published up to November 2020, were identified through PubMed, SCOPUS, and Embase databases. 15 studies, including 872 participants, were included and analyzed using a random-effects model to calculate weighted mean differences (WMDs) with 95% confidence intervals (CI). Findings from 15 studies indicated that vitamin C supplementation significantly decreased Triglyceride (TG) (WMD: -16.48 mg/dl, 95% CI (-31.89, -1.08), P < 0.001) and total cholesterol (TC) (WMD: -13.00 mg/dl, 95% CI (-23.10, -2.91), P < 0.001) in patients with T2DM. However, vitamin C supplementation failed to improve LDL and HDL. The meta-regression analysis suggested that lipid profile improvement was affected by duration of vitamin C treatment. Dose-response analysis showed that vitamin C supplementation changed LDL significantly based on vitamin C dose. According to our findings, vitamin C supplementation significantly improved lipid profile via decreases in TG and TC. However, vitamin C failed to affect LDL and HDL in diabetic populations. It appears that vitamin C supplementation is more beneficial to lipid profile in long-term vs. short term interventions.
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Ácido Ascórbico/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Lipídeos/sangue , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/farmacologia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/metabolismo , Suplementos Nutricionais , Relação Dose-Resposta a Droga , Humanos , Metabolismo dos Lipídeos/efeitos dos fármacosRESUMO
BACKGROUND AND AIM: The adipokine zinc-alpha2-glycoprotein (ZAG), a multidisciplinary protein, is involved in lipid metabolism, glucose homeostasis and energy balance. Accumulating evidence demonstrates that the expression of ZAG is mainly downregulated in obesity and obesity-related conditions. In the present study, we assessed the association of ZAG with non-alcoholic fatty liver disease (NAFLD) and the related risk factors including obesity, metabolic factors and inflammatory parameters, with emphasis on potential mechanisms underlying these associations. METHODS: PRISMA guidelines were followed in this review. Systematic searches were performed using the PubMed/Medline, ScienceDirect, Scopus, EMBASE, ProQuest and Google Scholar databases, up to August 2020 for all relevant published papers. RESULTS: Out of 362 records screened, 34 articles were included in the final analysis. According to the studies reviewed here, ZAG appears to exert a protective effect against NAFLD by enhancing mRNA expression levels of peroxisome proliferator-activated receptor α (PPARα) and PPARγ, promoting mRNA expression levels of the lipolysis-related genes, reducing mRNA expression levels of the lipogenesis-related genes, increasing hepatic fatty acid oxidation, ameliorating hepatic steatosis, promoting the activity of brown adipose tissue and the expression of thermogenesis-related genes, modulating energy balance and glucose homeostasis, and elevating plasma levels of healthy adipokines such as adiponectin. ZAG can also be involved in the regulation of inflammatory responses by attenuation of the expression of pro-inflammatory and pro-fibrotic mediators. CONCLUSION: According to the studies reviewed here, ZAG is suggested to be a promising therapeutic target for NAFLD. However, the favourable effects of ZAG need to be confirmed in prospective cohort studies.
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Hepatopatia Gordurosa não Alcoólica , Adipocinas , Glicoproteínas , Humanos , Fígado , Estudos Prospectivos , ZincoRESUMO
BACKGROUND AND OBJECTIVES: Naringenin has been reported to have some promising pharmacological effects on the management of obesity and related metabolic complications including non-alcoholic fatty liver disease (NAFLD). Therefore, the present clinical trial study was done to assess the effects of naringenin supplementation on lipid profile, aminotransferase levels, severity of steatosis, as well as probability of fibrosis in overweight/obese patients with NAFLD. MATERIALS AND METHODS: This placebo-controlled, parallel randomised, double-blind clinical trial study was conducted on 44 eligible overweight/obese patients with NAFLD (naringenin-treated group (n = 22), control group (n = 22)) referred to the national Iranian oil company (NIOC) Central Hospital, Tehran City, Tehran Province, Iran. Participants were randomly assigned to receive naringenin capsules (100 mg) and identical placebo capsules twice a day, before lunch and dinner, for 4 weeks. The primary outcomes were improvement of liver steatosis and NAFLD fibrosis score (NFS), and secondary outcomes included changes in levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lipid profile. RESULTS: Naringenin consumption significantly reduced percentages of NAFLD grades (P < .001), as well as, serum levels of triglyceride (TG) (P < .001), total cholesterol (TC) (P = .01), and low-density lipoprotein (LDL) (P = .02) and increased serum level of high-density lipoprotein (HDL) (P = .02) compared with the control group. Even after adjusting for the confounders, the results were significant. However, there were no significant changes in AST, ALT and NFS. CONCLUSION: Our findings revealed that daily intake of 200 mg of naringenin for 4 weeks had beneficial effects on lipid profile and percentages of NAFLD grades as an indicator for the severity of hepatic steatosis. Although, NFS values and serum levels of aminotransferase enzymes including AST and ALT did not remarkably change.
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Hepatopatia Gordurosa não Alcoólica , Suplementos Nutricionais , Método Duplo-Cego , Flavanonas , Humanos , Irã (Geográfico) , Lipídeos , Fígado , Cirrose Hepática , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Obesidade/complicações , Obesidade/tratamento farmacológico , Sobrepeso/complicações , Sobrepeso/tratamento farmacológico , ProbabilidadeRESUMO
BACKGROUND: Rhus coriaria L., commonly known as Sumac, is a plant from the Anacardiaceae family that is known for its high phytochemical content. These phytochemicals have the potential to effectively manage inflammation and oxidative stress. To explore the existing evidence on the impact of Sumac consumption on inflammation and oxidative stress, we conducted a systematic review of randomized controlled trials. METHODS: We conducted a comprehensive search of Medline/PubMed, Scopus, and Web of Science from inception to August 2023 to identify relevant studies examining the effects of Sumac on biomarkers of inflammation and oxidative stress. The selected studies were assessed for risk of bias using the Cochrane tool. RESULTS: A total of seven trials were included in this review. Among these trials, three focused on diabetes patients, while the remaining four involved individuals with fatty liver, overweight individuals with depression, and those with polycystic ovary or metabolic syndrome. Five studies reported the effects of Sumac on oxidative stress, with four of them demonstrating a significant reduction in malondialdehyde (MDA) levels and an increase in total antioxidant capacity (TAC) and paraoxonase 1 (PON1). Regarding inflammation, one study reported no significant difference in tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) levels between the intervention and control groups. The results for high-sensitivity C-reactive protein levels, reported in five trials, were inconsistent. CONCLUSION: Sumac consumption over time may positively affect oxidative stress, although short-term use shows minimal impact. While one study found no significant effect on IL-6 and TNF-α, hs-CRP levels could decrease or remain unchanged. Further meta-analyses are needed to fully understand Sumac's potential benefits in managing metabolic diseases.
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INTRODUCTION: There is a growing interest in the considerable benefits of grape products intake, as some studies have indicated that they may improve cardiometabolic risk factors. However, the widespread impact of grape products on the anthropometric indices is not fully resolved. METHOD: The purpose of this systematic review and meta-analysis was to examine the effects of grape products intake on anthropometric indices in adults. Randomized controlled trials (RCT) examining the effects of grape products intake on anthropometric indices, published up to December 2021, were identified through PubMed, SCOPUS, and ISI Web of Science databases. 30 studies with 35 effect sizes, including 1284 participants (708 cases and 576 controls), were included and analyzed using a random-effects model to calculate weighted mean differences (WMDs) with 95% confidence interval (CI). RESULT: The outcomes have revealed grape products intake to significantly decrease body weight (p = 0.001) and body mass index (p = 0.004) in obese participants, and also, a greater effect was observed when grape seed extract was used. CONCLUSION: Our study suggests that grape products intake may help to decrease body weight in obese participants. Future large RCTs with longer duration and obese populations are needed to expand our findings.
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Índice de Massa Corporal , Peso Corporal , Obesidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Vitis , Humanos , Vitis/química , Obesidade/tratamento farmacológico , Adulto , Peso Corporal/efeitos dos fármacos , Extrato de Sementes de Uva/farmacologia , Extrato de Sementes de Uva/administração & dosagemRESUMO
Promoting sustainability in food and nutrition systems is essential to address the various challenges and trade-offs within the current food system. This imperative is guided by key principles and actionable steps, including enhancing productivity and efficiency, reducing waste, adopting sustainable agricultural practices, improving economic growth and livelihoods, and enhancing resilience at various levels. However, in order to change the current food consumption patterns of the world and move toward sustainable diets, as well as increase productivity in the food production chain, it is necessary to employ the findings and achievements of other sciences. These include the use of artificial intelligence-based technologies. Presented here is a narrative review of possible applications of artificial intelligence in the food production chain that could increase productivity and sustainability. In this study, the most significant roles that artificial intelligence can play in enhancing the productivity and sustainability of the food and nutrition system have been examined in terms of production, processing, distribution, and food consumption. The research revealed that artificial intelligence, a branch of computer science that uses intelligent machines to perform tasks that require human intelligence, can significantly contribute to sustainable food security. Patterns of production, transportation, supply chain, marketing, and food-related applications can all benefit from artificial intelligence. As this review of successful experiences indicates, artificial intelligence, machine learning, and big data are a boon to the goal of sustainable food security as they enable us to achieve our goals more efficiently.
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BACKGROUND AND AIM: It has been suggested that taking vitamin C supplements may improve glycemic control in patients with type 2 diabetes mellitus (T2DM). However, there has not been a thorough evaluation of the actual impact or certainty of the findings. This systematic review and meta-analysis was conducted to determine the effect of vitamin C supplementation on glycemic profile in T2DM patients. METHODS: A systematic search was performed across online databases including Scopus, Web of Science, and PubMed/Medline to identify relevant randomized controlled trials (RCTs) published until July 2022. A random-effects model was applied for the meta-analysis. RESULTS: The present meta-analysis included a total of 22 RCTs with 1447 patients diagnosed with T2DM.A pooled analysis revealed a significant decrease in levels of serum hemoglobin A1c (HbA1c), fasting insulin, and fasting blood glucose (FBG) in vitamin C-treated T2DM patients compared with their untreated counterparts. The dose-response evaluation displayed a substantial linear association between the intervention duration and changes in serum HbA1c levels. However, the analysis did not demonstrate any significant effect of vitamin C on serum values of homeostasis model assessment of insulin resistance(HOMA-IR) in diabetic patients. Subgroup analyses indicated that high-dose vitamin C administration (≥1000 mg/d) considerably decreased serum HOMA-IR levels. CONCLUSION: These findings suggest that long-term (≥12 weeks) and high-dose vitamin C supplementation (≥1000 mg/d) may ameliorate glycemic profile in T2DM patients. However, additional high-quality RCTs are necessary to validate these results.
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Glicemia , Diabetes Mellitus Tipo 2 , Humanos , Hemoglobinas Glicadas , Glicemia/análise , Vitamina D , Controle Glicêmico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Vitaminas/uso terapêutico , Suplementos Nutricionais , Ácido Ascórbico/uso terapêuticoRESUMO
Objective: Cinnamon is extracted from the inner bark of Cinnamomum trees. Recent studies have indicated that cinnamon is a safe and cost-effective treatment for improving body weight, lipid profiles, insulin resistance, and blood pressure. This systematic review aimed to summarize the effect of cinnamon supplementation on adipokines and appetite-regulating hormones. Materials and Methods: This comprehensive literature search was conducted using databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar up to March 2022 without any limitation. The quality of eligible studies was evaluated through the Cochrane Collaboration's tool for assessing the risk of bias. Results: This systematic review included six clinical trial studies (363 participants), among which, only one study was performed on children, and two investigations were conducted on obese participants. A decreasing effect was found in the level of leptin and visfatin after cinnamon supplementation. Two out of three studies examined adiponectin levels and revealed non-significant effects of cinnamon consumption on this parameter. Two studies evaluated ghrelin levels and found an increase after cinnamon supplementation. The result of cinnamon supplementation on other biomarkers such as glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and resistin was inconsistent. Conclusion: The result of this systematic review indicated the increasing effect of cinnamon supplementation on ghrelin levels and decreasing effect on leptin and visfatin levels. However, more clinical data are required to clarify the beneficial effects of cinnamon on adipokines levels due to the controversial findings of the studies.
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OBJECTIVE: Although several experimental models have suggested promising pharmacological effects of naringenin in the management of obesity and its related disorders, the effects of naringenin supplementation on cardiovascular disorders as one of the main complications of nonalcoholic fatty liver disease (NAFLD) are yet to be examined in humans. METHODS: In this double-blind, placebo-controlled, randomized clinical trial, 44 overweight/obese patients with NAFLD were equally allocated into either naringenin or placebo group for 4 weeks. Cardiovascular risk factors including atherogenic factors, hematological indices, obesity-related parameters, blood pressure, and heart rate were assessed pre- and postintervention. RESULTS: The atherogenic index of plasma value, serum non-HDL-C levels as well as total cholesterol/high-density lipoprotein cholesterol (HDL-C), triglyceride/HDL-C, low-density lipoprotein cholesterol/HDL-C, and non-HDL-C/HDL-C ratios were significantly reduced in the intervention group, compared to the placebo group post intervention (P < 0.05). Moreover, there was a significant reduction in BMI and visceral fat level in the intervention group when compared with the placebo group (P = 0.001 and P = 0.039, respectively). Furthermore, naringenin supplementation could marginally reduce systolic blood pressure (P = 0.055). Mean corpuscular hemoglobin increased significantly in the naringenin group compared to the placebo group at the endpoint (P = 0.023). Supplementation with naringenin also resulted in a marginally significant increase in the mean corpuscular hemoglobin concentration when compared with the placebo group (P = 0.050). There were no significant between-group differences for other study outcomes post intervention. CONCLUSION: In conclusion, these data indicate that naringenin supplementation may be a promising treatment strategy for cardiovascular complications among NAFLD patients. However, further trials are warranted.
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Doenças Cardiovasculares , Hepatopatia Gordurosa não Alcoólica , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Suplementos Nutricionais , Método Duplo-Cego , Flavanonas , Fatores de Risco de Doenças Cardíacas , Humanos , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Obesidade/complicações , Sobrepeso/complicações , Sobrepeso/tratamento farmacológico , Fatores de RiscoRESUMO
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of liver dysfunction worldwide. Recently, some natural compounds have attracted growing interest in the treatment of NAFLD. In this context, most attention has been paid to natural products derived from fruits, vegetables, and medicinal herbs. Naringenin, a natural flavanone, has been revealed to have pharmacological effects in the treatment of obesity and associated metabolic disorders such as NAFLD. The aim of this study was to examine the therapeutic effects of naringenin and its possible mechanisms of action in the management of NAFLD and related risk factors. The current systematic review was performed according to the guidelines of the 2015 PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) statements. We searched PubMed/Medline, Science Direct, Scopus, ProQuest, and Google Scholar databases up until February 2020. Of 1217 full-text articles assessed, 36 studies met the inclusion criteria. The evidence reviewed in the present study indicates that naringenin modulates several biological processes related to NAFLD including energy balance, lipid and glucose metabolism, inflammation, and oxidative stress by different mechanisms. Overall, the favorable effects of naringenin along with its more potency and efficacy, compared with other antioxidants, indicate that naringenin may be a promising therapeutic approach for the management of NAFLD and associated complications. However, due to the lack of clinical trials, future robust human randomized clinical trials that address the effects of naringenin on NAFLD and other liver-related diseases are crucial. Further careful human pharmacokinetic studies are also needed to establish dosage ranges, as well as addressing preliminary safety and tolerability of naringenin, before proceeding to larger-scale endpoint trials.
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Citrus , Flavanonas , Hepatopatia Gordurosa não Alcoólica , Flavanonas/farmacologia , Flavanonas/uso terapêutico , Flavonoides/farmacologia , Flavonoides/uso terapêutico , Humanos , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Fatores de RiscoRESUMO
INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is one of the main causes of chronic liver disease worldwide. Flavonoids, a group of natural compounds, have garnered a great deal of attention in the management of NAFLD because of their profitable effects on glucose and lipid metabolism, inflammation, and oxidative stress which are the pivotal pathophysiological pathways in NAFLD. Naringenin is a citrus-derived flavonoid with a broad spectrum of potential biological effects including anti-inflammatory and antioxidant properties, which may exert protective effects against NAFLD. The present clinical trial aims to examine the efficacy of naringenin supplementation on plasma adiponectin and neurogulin-4 (NRG-4) concentrations, metabolic parameters, and liver function indices in overweight/obese patients with NAFLD. METHODS AND ANALYSIS: This is a double-blind, randomized, placebo-controlled clinical study that will investigate the impacts of naringenin supplementation in overweight/obese patients with NAFLD. Liver ultrasonography will be applied to diagnose NAFLD. Forty-four eligible overweight/obese subjects with NAFLD will be selected and randomly assigned to receive naringenin capsules or identical placebo (each capsule contains 100 mg of naringenin or cellulose), twice daily for 4 weeks. Participants will be asked to remain on their usual diet and physical activity. Safety of naringenin supplementation was confirmed by the study pharmacist. The primary outcome of this study is changes in adiponectin circulating levels. The secondary outcomes include changes in NRG-4 levels, liver function indices, metabolic parameters, body weight, body mass index (BMI), waist circumference (WC), blood pressure, and hematological parameters. Statistical analysis will be conducted using the SPSS software (version 25), and P value less than 0.05 will be regarded as statistically significant. DISCUSSION: We hypothesize that naringenin administration may be useful for treating NAFLD by modulating energy balance, glucose and lipid metabolism, oxidative stress, and inflammation through different mechanisms. The current trial will exhibit the effects of naringenin, whether negative or positive, on NAFLD status. ETHICAL ASPECTS: The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1399.439). TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT201311250155336N12 . Registered on 6 June 2020.