Wheat germ improves hepatic steatosis, hepatic enzymes, and metabolic and inflammatory parameters in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled, double-blind clinical trial.

Globally, Non-alcoholic fatty liver disease (NAFLD) has a rising prevalence with no definitive pharmacological treatments. The aim of this study was to assess the clinical effects of wheat germ in patients with NAFLD. Fifty participants with NAFLD were randomly allocated to take 40 g wheat germ (n = 25) or placebo (n = 25) in a randomized double-blind clinical trial over 12 weeks. Transient elastography (FibroScan) determined a diagnosis of NAFLD. After 12 weeks of intervention, reduction in serum alanine aminotransferase (p = 0.006) and γ-glutamyltransferase (p = 0.004), total cholesterol (p = 0.018), triglyceride (p = 0.046), and hepatic steatosis (p = 0.043) levels in the wheat germ group was significantly higher compared to the placebo group. Serum TAC levels in wheat germ group patients increased significantly higher than placebo group (p = 0.001). Reduction in serum hs-CRP level in the wheat germ group was significantly higher than in the placebo group (p = 0.031). In conclusion, our study shows that wheat germ consumption may improve total antioxidant capacity, hepatic steatosis, serum total cholesterol and triglyceride levels, alanine aminotransferase (ALT), and Gamma-glutamyl Transferase (GGT) in NAFLD patients. Longitudinal studies with larger sample sizes are needed to confirm biological effects of wheat germ on NAFLD patients.

The efficacy of flaxseed and hesperidin on non-alcoholic fatty liver disease: an open-labeled randomized controlled trial.

BACKGROUND/OBJECTIVES: Non-alcoholic fatty liver disease (NAFLD) is growing in prevalence globally and no definitive evidence for any approved pharmacological approaches for patients with NAFLD has been found yet. This study was aimed to assess the clinical effects of flaxseed and hesperidin in patients with NAFLD. SUBJECTS/METHODS: In this randomized, controlled, clinical trial, one hundred eligible patients with NAFLD were enrolled and randomly assigned to four dietary intervention groups including lifestyle modification program (control), lifestyle modification program with 30 g whole flaxseed powder, lifestyle modification program with 1 g hesperidin supplementation, and lifestyle modification program with combination of 30 g flaxseed and 1 g hesperidin (flax-hes) for 12 weeks. The changes in anthropometric parameters, metabolic profiles of glucose and lipids, inflammatory biomarkers and hepatic steatosis and fibrosis were evaluated. RESULTS: After the 12-week dietary interventions, significant reductions in body mass index, glucose hemostasis parameters and hepatic steatosis were observed in all groups. Repeated measures analysis of variance revealed a significant effect for time relative to almost all paraclinical parameters. Post hoc analysis with Bonferroni correction revealed that the three intervention groups experienced significant decreases in plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index compared to control (p < 0.008). CONCLUSIONS: In conclusion, our study confirmed that hesperidin and flaxseed supplementation improved glucose and lipid metabolism, while reduced inflammation and hepatic steatosis (controlled attenuation parameter) in NAFLD patients. The synergistic effects of their combination were observed on plasma glucose concentration and HOMA-IR.

The effect of hesperidin supplementation on metabolic profiles in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial.

PURPOSE: Hesperidin as an antioxidant flavonoid exerts anti-adipogenic, anti-inflammatory, anti-oxidant and anti-hypercholesterolemic effects. Besides, the increasing prevalence of metabolic syndrome (MetS) and its allied complications, on the one hand, and the willingness of individuals to use natural products for curing their diseases, on the other hand, led to the design of this study to evaluate the efficacy of hesperidin in normalizing the metabolic abnormalities in patients with MetS. METHODS: In this clinical trial with a parallel-group design, 49 patients with MetS received either 500-mg hesperidin or placebo, twice daily, for 12 weeks. Number of participants with treated MetS was considered as a primary end point. Anthropometric parameters, dietary intake, physical activity, lipid profile, glucose homeostasis parameter, tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP) were assessed at the beginning and at the end of the study. This trial is registered at clinicaltrials.gov as NCT03734874. RESULTS: Compared with the placebo group, hesperidin decreased fasting glucose level (- 6.07 vs. - 13.32 mg/dL, P = 0.043), triglyceride (- 8.83 vs. - 49.09 mg/dL, P = 0.049), systolic blood pressure (- 0.58 vs. - 2.68 mmHg, P = 0.048) and TNF-α (- 1.29 vs. - 4.44 pg/mL, P = 0.009). Based on the within-group analysis, hesperidin led to significant decrease in serum levels of glucose, insulin, triglyceride, total cholesterol, low density lipoprotein cholesterol, TNF-α and hs-CRP, while in control group only glucose and insulin significantly decreased. CONCLUSIONS: The results indicate that hesperidin supplementation can improve metabolic abnormalities and inflammatory status in patients with MetS.

Hesperidin improves hepatic steatosis, hepatic enzymes, and metabolic and inflammatory parameters in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled, double-blind clinical trial.

This study aimed to evaluate the effects of hesperidin on nonalcoholic fatty liver disease (NAFLD) characteristics. In this randomized, double-blind, controlled clinical trial, 50 NAFLD patients were supplemented with either 1-g hesperidin capsule or identical placebo capsule for 12 weeks. During the intervention, both groups were advised to follow healthy lifestyle habits including dietary and physical activity recommendations. At the end of the study, hesperidin supplementation, compared with placebo, was associated with a significant reduction in alanine aminotransferase (p = .005), γ-glutamyltransferase (p = .004), total cholesterol (p = .016), triglyceride (p = .049), hepatic steatosis (p = .041), high-sensitivity C-reactive protein (p = .029), tumor necrosis factor-α, and nuclear factor-κB (NF-κB). In conclusion, our results indicate that hesperidin supplementation accompanied with lifestyle modification is superior to lifestyle modification alone in management of NAFLD at least partially through inhibiting NF-κB activation and improving lipid profile. Further studies with higher dose of hesperidin are required to find the optimal dose.

Green cardamom supplementation improves serum irisin, glucose indices, and lipid profiles in overweight or obese non-alcoholic fatty liver disease patients: a double-blind randomized placebo-controlled clinical trial.

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.

Efficacy of nanocurcumin supplementation on insulin resistance, lipids, inflammatory factors and nesfatin among obese patients with non-alcoholic fatty liver disease (NAFLD): a trial protocol.

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.

The effects of green cardamom on blood glucose indices, lipids, inflammatory factors, paraxonase-1, sirtuin-1, and irisin in patients with nonalcoholic fatty liver disease and obesity: study protocol for a randomized controlled trial.

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.

Hepatoprotective effect of quercetin: From chemistry to medicine.

Liver diseases caused by viral hepatitis infections have a negative impact on global health. Approximately 30 million people in the USA and 29 million people in the European Union suffer from chronic liver disease. There are many kinds of diseases of the liver, caused by viruses, such as hepatitis A, hepatitis B and hepatitis C, or by certain drugs and poisons including excessive alcohol consumption. Many herbal medicines are used in traditional medicine for their protective and therapeutic properties against liver diseases. Among their bioactive components, flavonoids have been found to be active against liver dysfunction and damage caused by liver diseases. Extensive evidences report that quercetin (QE), a major flavonol commonly found in apple, berries, onion, citrus fruits, cruciferous vegetables, tea, pepper, tomato, whole gain, cocoa and red wine, displays a wide range of healthy properties, including anti-oxidative, anti-inflammatory, anti-apoptotic and hepatoprotective activities against various hepatic ailments. This review aims to critically analyze the available literature regarding the hepatoprotective effects of QE with special emphasis on its mechanisms of actions. To provide a complete picture of QE, its distribution, chemistry, biosynthesis and bioavailability are reported. Overall, data in literature shows that QE appears to be a promising hepatoprotective compound.

Protective Effect of Cornus mas Fruits Extract on Serum Biomarkers in CCl4-Induced Hepatotoxicity in Male Rats.

BACKGROUND: Nowadays attention to use herbs such as cornelian cherry (Cornus mas) is increasing, which contains high levels of antioxidants and anthocyanins. Cornus mas fruits have been used for gastrointestinal and excretory disorders for many years in traditional medicine, also may improve liver and kidney functions, and have protective effects such as anti-allergic, antidiabetic, antibacterial, antimicrobial, antihistamine and antimalarial properties. OBJECTIVES: The aim of this study was to investigate protective effects of Cornus mas fruits extract on serum biomarkers in CCl4-induced hepatotoxicity in male rats. MATERIALS AND METHODS: Hepatotoxicity was induced by administration of carbon tetrachloride (1 mL/kg i.p.) in 1:1 dilution with olive oil. To evaluate the effect of Cornus mas fruits extract on disease progression, serum marker enzymes, serum total protein and albumin and liver lipid peroxidation were determined in CCl4-induced hepatotoxicity. RESULTS: Oral administration of Cornus mas fruits extract to rats for 14 days provided a significant (P < 0.05) hepatoprotection by decreasing elevated serum level of enzymes, total serum protein, albumin and liver lipid peroxidation content. CONCLUSIONS: Cornus mas fruit extract effect may be due to including some antioxidant components, which caused membrane stabilizing and normalization of fluctuated biochemical profiles induced by CCl4 exposure. Our results validated the traditional use of Cornus mas in the treatment of liver disorders.

Effect of zinc supplementation on viral response in patients with chronic hepatitis C and Beta thalassemia major, a pilot study.

INTRODUCTION: Zinc deficiency has been reported in patients with both hepatitis C and beta thalassemia major. Zinc supplementation in addition to antiviral therapy of chronic hepatitis C has been accompanied by some success in patients with chronic hepatitis C. OBJECTIVE: The aim of the present pilot study is to determine the effect of 30 mg elemental zinc on biochemical and virological response in a population of patients with chronic hepatitis C with beta thalassemia major. MATERIALS AND METHODS: A prospective, double blind,placebo controlled trial included 40 patients being treated with Pegylated interferon Alfa (Peg IFN-α) and ribavirin. Biochemical and virological parameters and plasma zinc levels were determined before starting treatment. Patients were randomly selected to receive either zinc or a placebo in addition to Peg IFN-α and ribavirin for a period of one year. AST, ALT, sustained viral response (SVR), and zinc levels were measured after treatment.Of the original 40 eligible patients, eight withdrawn from the study and 32 patients completed the study; 16 in the zinc group and 16 in the placebo group. Analysis of the data shows that there is no difference between the two groups in AST, ALT, SVR or zinc level following one year of treatment (p=0.224, p=0.616, p=0.670, p=0.999, respectively). CONCLUSION: The results of this study indicate that using 30 mg/day elemental zinc did not significantly improve the outcome of treatment in thalassemia patients with chronic hepatitis C. In future studies, we recommend trying higher doses zinc in patients with hepatitis C who had beta thalassemia major.

Plasma zinc level in hepatitis C patients with or without Beta thalassemia major; is there any difference?

BACKGROUND: Zinc deficiency has been reported frequently in hepatitis C patients in the literature. Furthermore, a decrease in zinc level has been shown in beta thalassemia major as well. Iranians consume a large amount of phytate in their regimens which can bind with zinc and decrease its gastrointestinal absorption. OBJECTIVES: This study was designed to determine plasma zinc level in an Iranian sample with the diagnosis of hepatitis C with or without concomitant beta thalassemia major. PATIENTS AND METHODS: Between April 2011 and April 2012, plasma zinc level was determined via atomic absorption method, in 130 hepatitis C patients with or without beta thalassemia major in a known referral center of hepatic diseases in Tehran, Iran. RESULTS: Mean ± standard deviation (SD) of plasma zinc levels was determined as 0.78 ± 0.22 mg/L. Also zinc level was 0.76 ± 0.19 mg/L and 0.80 ± 0.24 mg/L in thalassemic and non thalassemic patients, respectively. T-test analysis showed that there is no significant difference between these two groups regarding plasma zinc level (P = 0.235). CONCLUSIONS: It is concluded that zinc level of studied patients is less than which is reported in normal Iranian population. Moreover, there is not a significant difference in plasma zinc levels between thalassemic and non thalassemic patients and it seems to be a common problem in both ones. Addition of zinc supplement may be recommended in both groups in order to optimize the nutritional support and probably improve the treatment response.

Prevalence of hepatitis d virus infection among hepatitis B virus infected patients in qom province, center of iran.

BACKGROUND: Hepatitis D virus (HDV) is a defective RNA virus that depends on the hepatitis B surface antigen (HBsAg) of hepatitis B virus for its replication, developing exclusively in patients with acute or chronic hepatitis B. There are little data regarding the routes of HDV transmission in Iran. The risk factors for HDV infection in Iran are blood transfusion, surgery, family history, Hejamat wet cupping (traditional phlebotomy), tattooing, war injury, dental interventions, and endoscopy. OBJECTIVES: We performed this study to determine the prevalence of hepatitis D in the general population of Qom province and the potential risk factors for acquiring HDV. PATIENTS AND METHODS: This cross-sectional study collected 3690 samples from 7 rural clusters and 116 urban clusters. HBs antigen was measured, and if the test was positive, anti-HDV was measured. Ten teams, each consisting of 2 trained members, were assigned to conduct the sampling and administer the questionnaires. The data were analyzed using SPSS. RESULTS: Forty-eight subjects (1.3%) suffered from hepatitis B, and 1 HBsAg-positive case had HDV infection. The prevalence of hepatitis D infection in Qom Province was 0.03%. The prevalence of hepatitis D infection in HBsAg-positive cases was 2%. Our anti-HDV-positive case had a history of tattooing, surgery, and dental surgery. There was no significant relationship between tattooing, surgery history, or dental surgery and hepatitis D infection. CONCLUSIONS: The prevalence of hepatitis D in Qom is the the lowest in Iran, similar to a study in Babol (north of Iran).

Vitamin D insufficiency among children and adolescents living in Tehran, Iran.

Vitamin D is important for calcium absorption and skeletal growth. Vitamin D insufficiency (VDI) is a prevalent health problem in children. A study was performed to determine the prevalence of VDI in healthy children living in Tehran, Iran. In a cross-sectional study, 963 students (424 boys and 539 girls) aged 7-18 years were selected by random sampling. Serum 25-hydroxyvitamin D (25-OHD), calcium, alkaline phosphatase and phosphorus were measured. VDI was defined as serum 25-OHD <20 ng/ml. Prevalence of VDI was 53.6% in girls and 11.3% in boys. VDI in female students was about five times more common than males (p < 0.000001). VDI in children and adolescent girls is a health problem not only for these age-groups but also for the next generation to come. Encouraging girls to have more sun exposure, fortification of foods and prescription of supplemental vitamin D are recommended.