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Evaluation of the Effect Derived from Silybin with Vitamin D and Vitamin E Administration on Clinical, Metabolic, Endothelial Dysfunction, Oxidative Stress Parameters, and Serological Worsening Markers in Nonalcoholic Fatty Liver Disease Patients.
Federico, A, Dallio, M, Masarone, M, Gravina, AG, Di Sarno, R, Tuccillo, C, Cossiga, V, Lama, S, Stiuso, P, Morisco, F, et al
Oxidative medicine and cellular longevity. 2019;:8742075
Abstract
Nowadays, the nonalcoholic fatty liver disease represents the main chronic liver disease in the Western countries, and the correct medical therapy remains a big question for the scientific community. The aim of our study was to evaluate the effect derived from the administration for six months of silybin with vitamin D and vitamin E (RealSIL 100D®) on metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease markers in nonalcoholic fatty liver disease patients. We enrolled 90 consecutive patients with histological diagnosis of nonalcoholic fatty liver disease and 60 patients with diagnosis of reflux disease (not in therapy) as healthy controls. The nonalcoholic fatty liver disease patients were randomized into two groups: treated (60 patients) and not treated (30 patients). We performed a nutritional assessment and evaluated clinical parameters, routine home tests, the homeostatic model assessment of insulin resistance, NAFLD fibrosis score and fibrosis-4, transient elastography and controlled attenuation parameter, thiobarbituric acid reactive substances, tumor necrosis factor α, transforming growth factor β, interleukin-18 and interleukin-22, matrix metalloproteinase 2, epidermal growth factor receptor, insulin growth factor-II, cluster of differentiation-44, high mobility group box-1, and Endocan. Compared to the healthy controls, the nonalcoholic fatty liver disease patients had statistically significant differences for almost all parameters evaluated at baseline (p < 0.05). Six months after the baseline, the proportion of nonalcoholic fatty liver disease patients treated that underwent a statistically significant improvement in metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease was greater than not treated nonalcoholic fatty liver disease patients (p < 0.05). Even more relevant results were obtained for the same parameters by analyzing patients with a concomitant diagnosis of metabolic syndrome (p < 0.001). The benefit that derives from the use of RealSIL 100D could derive from the action on more systems able to advance the pathology above all in that subset of patients suffering from concomitant metabolic syndrome.
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Vitamin D supplementation for the treatment of non-alcoholic fatty liver disease: A randomized double blind placebo controlled trial.
Dabbaghmanesh, MH, Danafar, F, Eshraghian, A, Omrani, GR
Diabetes & metabolic syndrome. 2018;(4):513-517
Abstract
BACKGROUND Low serum vitamin D has been associated with metabolic syndrome and Non-alcoholic fatty liver disease (NAFLD). This study aimed to investigate the impact of vitamin D supplementation in treatment of patients with NAFLD. METHODS In a double blind, randomized, placebo controlled trial patients with NAFLD were randomized to receive one weekly pearl of placebo, 50,000 U vitamin D3 (cholecalciferol) pearl per week and 0.25 mg calcitriol (1,25 dihydroxycholecalciferol) pearl per day for 3 months. RESULTS 106 NAFLD patients were randomized to receive calcitriol, vitamin D3 and placebo pearls for 12 weeks and data for 91 patients were analyzed. After 12 weeks of treatment, serum alkaline phosphatase levels was significantly decreased from baseline levels in vitamin D and calcitriol treated groups (P < 0.05). Serum and gamma glutamyl transferase (GGT) level was also significantly decreased compared to the baseline levels after 12 weeks of treatment with vitamin D. There was no statistically significant difference between placebo, calcitriol, vitamin D groups in terms of serum aminotransferase, alkaline phosphatase, serum GGT and lipid profile (P > 0.05). CONCLUSION While significant reduction of serum alkaline phosphatase and GGT were seen with vitamin D and calcitriol supplementation from baseline levels, no beneficial effects was seen when comparing vitamin D, calcitriol and placebo groups at the end of trial.
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Genistein supplementation improves insulin resistance and inflammatory state in non-alcoholic fatty liver patients: A randomized, controlled trial.
Amanat, S, Eftekhari, MH, Fararouei, M, Bagheri Lankarani, K, Massoumi, SJ
Clinical nutrition (Edinburgh, Scotland). 2018;(4):1210-1215
Abstract
BACKGROUND & AIMS The beneficial effect of genistein has indicated on metabolic disorders and inflammatory state. The aim of this study was to investigate the effect of genistein supplementation on non-alcoholic fatty liver disease (NAFLD) as the hepatic manifest of metabolic syndrome. METHODS In the present randomized double-blind controlled trial, patients with NAFLD were daily supplemented with either 250 mg genistein (n = 41) or placebo (n = 41) for 8-weeks. Both groups were instructed to follow an energy-balanced diet and physical activity recommendations. And their anthropometric and biochemical indices were assessed before and after the intervention. RESULTS At the end of the study, the genistein group had lower level of serum insulin (p = 0.001) and homeostasis model assessment for insulin resistance (HOMA-IR) (p = 0.041) compare to the placebo group. In addition serum malondialdehyde (MDA) (p = 0.004), tumor necrosis factor-α (TNF-α) (p = 0.045) and interleukin (IL)-6 (p = 0.018) also were lower in the genistein group. Compare with placebo, genistein supplementation significantly reduced waist to hip ratio (p = 0.021), body fat percentage (p = 0.015) and triglyceride (p = 0.018). However, there were no significant changes in BMI, fasting blood glucose (p = 0.122), alanine aminotransferase (ALT) (p = 0.536), aspartate aminotransferase (AST) (p = 0.265) between the two groups. CONCLUSIONS Oral supplementation with 250 mg genistein for 8-weeks can reduce insulin resistance, oxidative and inflammatory indices along with improvement in fat metabolism in patients with NAFLD. Studies with longer duration and larger samples might be needed to reveal other beneficial effects of genistein.
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Placebo-controlled, randomised clinical trial: high-dose resveratrol treatment for non-alcoholic fatty liver disease.
Heebøll, S, Kreuzfeldt, M, Hamilton-Dutoit, S, Kjær Poulsen, M, Stødkilde-Jørgensen, H, Møller, HJ, Jessen, N, Thorsen, K, Kristina Hellberg, Y, Bønløkke Pedersen, S, et al
Scandinavian journal of gastroenterology. 2016;(4):456-64
Abstract
OBJECTIVE "The obesity epidemic" has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease (NAFLD), for which effective treatments are in demand. The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction. We aimed to test the hypothesis that resveratrol alleviates NAFLD in a randomised, clinical trial. MATERIALS AND METHODS A total of 28 overweight patients with transaminasemia and histological NAFLD were randomised 1:1 to placebo or resveratrol 1.5 g daily for 6 months. Twenty-six participants completed the trial and underwent repeated clinical investigation, blood work, MR spectroscopy; and 19 participants agreed to a repeat liver biopsy. RESULTS Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury (primary outcome: alanine transaminase, p = 0.51). Resveratrol-treated patients showed a 3.8% decrease in liver lipid content (p = 0.03), with no difference between the two treatment arms (p = 0.38) and no improvement of histological features. Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome, except for a transient decrease in systolic BP. Microarray analysis and qRT-PCR revealed no major changes in expression profile. Also, we report a serious adverse event in a patient who developed fever and bicytopenia. CONCLUSIONS In this placebo-controlled, high-dose and long-term study, resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD, though there may be a small ameliorating effect on liver function tests and liver fat accumulation.