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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., (© 2021. The Author(s).)

Background: Despite the reported health effects of cardamom on dyslipidemia, hepatomegaly, and fasting hyperglycemia, no human research has studied its potency in non-alcoholic fatty liver disease (NAFLD) as the hepatic part of metabolic syndrome. Our aim was determining the effects of green cardamom (GC) on serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients., Methods: The place of participant recruitment was the polyclinic of the National Iranian Oil Company (NIOC) central hospital in Tehran. Based on the ultrasonography and eligibility criteria, 87 participants were randomly divided into two groups as cardamom (n = 43) or placebo (n = 44). The supplementation was two 500 mg capsules 3 times/day with meals for 3 months. Serum irisin, fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) were measured. Quantitative insulin sensitivity check index (QUICKI) and homeostasis model assessment-insulin resistance (HOMA-IR) were also calculated., Results: In comparison with placebo, GC significantly increased irisin, HDL-c, and QUICKI and decreased FBI, TG, LDL-c, HOMA-IR, and the grade of fatty liver (P < 0.05). After adjustment for confounders, the changes were similar (P < 0.05) with an exception for LDL-c which had a trend (P = 0.07). The differences in FBS, TC, and body mass index (BMI) were not significant (P > 0.05)., Conclusion: GC supplement improved the grade of fatty liver, serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. The changes in these biomarkers may yield beneficial effects on NAFLD. Further trials on the efficacy of GC for clinical practice are suggested., Trial Registration: Iranian Registry of Clinical Trials, IRCT2015121317254N4 . Registered 27/12/2015.

Objectives: Different studies have been conducted on the role of curcumin in health since having multiple properties, including antioxidant and anti-inflammatory effects. Due to the lack of studies regarding curcumin effects on obese patients with non-alcoholic fatty liver disease (NAFLD), our protocol was designed to assess nanocurcumin impacts on blood sugar, lipids, inflammatory indices, insulin resistance and liver function, especially by nesfatin., Setting: This trial will be conducted in the Oil Company central hospital of Tehran, Iran with a primary level of care., Participants: 84 obese patients with NAFLD diagnosed using ultrasonography will be employed according to the eligibility criteria‎., Interventions: The patients will be randomly divided into two equal groups (nanocurcumin and placebo, two 40 mg capsules per day with meals for 3 months, follow-up monthly). Also, lifestyle changes (low-calorie diet and physical activity) will be advised., Measures of the Primary and Secondary Outcomes: A general questionnaire, 24 hours food recall (at the beginning, middle and end) and short-form International Physical Activity Questionnaire will be completed. Blood pressure, anthropometrics, serum sugar indices (fasting blood sugar and insulin, insulin resistance and sensitivity and glycosylated haemoglobin), lipids (triglyceride, total cholesterol and low-density and high-density lipoprotein-cholesterol, inflammatory profiles (interleukin-6, high-sensitivity C-reactive protein, and tumour necrosis factor-alpha), liver function (alanine and aspartate transaminase) and nesfatin will be measured at the beginning and end of the study., Conclusion: This trial would be the first experiment to determine nanocurcumin efficacy on certain blood factors among obese patients with NAFLD. Nevertheless, studying the potential consequences of curcumin in various diseases, especially NAFLD, is required for clinical use., Trial Registration Number: IRCT2016071915536N3; pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The relationship between dietary components and nonalcoholic fatty liver disease (NAFLD) needs to be further investigated. The potential health benefits of cardamom have been found in some studies. Cardamom showed beneficial effect on hepatomegaly, dyslipidemia, and fasting hyperglycemia in animals. However, some adverse effects of cardamom have been reported in animals. No previous human study had been conducted on the effects of cardamom in NAFLD. This study aims to determine the effects of green cardamom (Elettaria cardamomum) supplementation on blood glucose indices, lipids, inflammatory profiles, and liver function, especially by examining irisin, paraxonase-1 (PON1) and sirtuin-1 (Sirt1) in obese patients with NAFLD., Methods: This trial is to be conducted at the polyclinic of the National Iranian Oil Company (NIOC) Central Hospital, Tehran. Eighty obese patients with NAFLD will be selected according to the eligibility criteria. The NAFLD diagnosis method is ultrasonography. Patients will be randomly divided into two groups by a random-number table (cardamom and placebo groups, two 500-mg capsules, three times/day, taken with meals for 3 months, follow-up monthly). General characteristics, dietary intakes (at the beginning, middle, and end), and physical activity (at the beginning and end) will be assessed using a general, 24-h food recall, and short-form International Physical Activity Questionnaires (IPAQ), respectively. Lifestyle advice will be presented to both groups identically. At the beginning and the end, anthropometrics (weight, height, and waist circumference), blood pressure, extent of fatty liver, and blood biomarkers, including serum glucose indices (fasting blood sugar (FBS)) and insulin (FBI), homeostasis model assessment-insulin resistance (HOMA-IR), Quantitative Insulin Sensitivity Check Index (QUICKI)), lipids (triglyceride (TG), low-density lipoprotein-cholesterol (LDL-c), high-density lipoprotein-cholesterol (HDL-c), total cholesterol (TC)), inflammatory markers (highly sensitive C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6)), liver enzymes (alanine transaminase (ALT), aspartate transaminase (AST)), irisin, PON1, and Sirt1, will be determined., Discussion: This trial would be the first to assess the effects of green cardamom on several blood factors, including glucose indices, lipids, inflammatory markers, liver enzymes, irisin, PON1, and Sirt1, and blood pressure and anthropometry in obese patients with NAFLD. Further study of cardamom's potential in improving NAFLD is suggested., Trial Registration: Iranian Registry of Clinical Trials (IRCT), ID number: IRCT2015121317254N4 . Registered on 27 December 2015.

Background: Despite the reported health effects of cardamom on dyslipidemia, hepatomegaly, and fasting hyperglycemia, no human research has studied its potency in non-alcoholic fatty liver disease (NAFLD) as the hepatic part of metabolic syndrome. Our aim was determining the effects of green cardamom (GC) on serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. Methods: The place of participant recruitment was the polyclinic of the National Iranian Oil Company (NIOC) central hospital in Tehran. Based on the ultrasonography and eligibility criteria, 87 participants were randomly divided into two groups as cardamom (n = 43) or placebo (n = 44). The supplementation was two 500 mg capsules 3 times/day with meals for 3 months. Serum irisin, fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) were measured. Quantitative insulin sensitivity check index (QUICKI) and homeostasis model assessment-insulin resistance (HOMA-IR) were also calculated. Results: In comparison with placebo, GC significantly increased irisin, HDL-c, and QUICKI and decreased FBI, TG, LDL-c, HOMA-IR, and the grade of fatty liver (P < 0.05). After adjustment for confounders, the changes were similar (P <0.05) with an exception for LDL-c which had a trend (P = 0.07). The differences in FBS, TC, and body mass index (BMI) were not significant (P > 0.05). Conclusion: GC supplement improved the grade of fatty liver, serum glucose indices, lipids, and irisin level among overweight or obese NAFLD patients. The changes in these biomarkers may yield beneficial effects on NAFLD. Further trials on the efficacy of GC for clinical practice are suggested. [ABSTRACT FROM AUTHOR]