Efficacy of Phosphatidylcholine in NAFLD

Overview

This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. All participants with NAFLD will receive life style intervention and half of them will receive additionally Phosphatidylcholine.

Full Title of Study: “Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 3, 2019

Detailed Description

As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and its components which also increases the risk of more advanced disease both in adults and in children. Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. New concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. Further studies are needed to better characterize not only NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver fibrosis. Not much therapeutic options for NAFLD are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on NAFLD.

Interventions

  • Dietary Supplement: Phosphatidyl Choline
    • 2.1 g Phosphatidylcholine daily in addition to lifestyle modification
  • Behavioral: Lifestyle modification
    • Lifestyle modification and health education by Clinical Pharmacist

Arms, Groups and Cohorts

  • Experimental: Intervention Group
    • 50 Participants with NAFLD that receive lifestyle modification by Clinical Pharmacist plus Phosphatidylcholine two soft capsules 3 times daily(2.1 g per day) for 6 month
  • Active Comparator: Control Group
    • 50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline Body Mass Index (BMI) at 3 and 6 month
    • Time Frame: baseline, at 3 and 6 month
    • person’s weight in kilograms divided by the square of the person’s height in metres (kg/m2).
  • change from baseline liver stiffness at 3 and 6 month
    • Time Frame: baseline , at 3 and 6 month
    • Liver Stiffness and fibrosis score measured by Transient elastography (Fibroscan) F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis
  • change from baseline Lipid Profile
    • Time Frame: baseline , at 3 and 6 month
    • Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein
  • change from baseline Oxidative stress markers
    • Time Frame: baseline , at 3 and 6 month
    • malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay
  • change from baseline NAFLD score at 3 and 6 month
    • Time Frame: baseline , at 3 and 6 month
    • NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, albumin, platelet count, AST/ALT ratio) and it is calculated using published formula (http: //naflds- core.com) . A low cutpoint (score < -1.455) signified the absence of advanced fibrosis, whereas a high cutpoint (score> 0.676) identified advanced fibrosis.
  • change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month
    • Time Frame: baseline , at 3 and 6 month
    • HOMA IR scores <3 normal HOMA IR scores >5 severe insulin resistance 3 to 5 moderate insulin resistance

Secondary Measures

  • change from baseline Complete Blood Picture at 3 and 6 month
    • Time Frame: baseline , at 3 and 6 month
    • platelet count

Participating in This Clinical Trial

Patients were included in the study when the following criteria to were fulfilled : Inclusion Criteria:

  • fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT) – the presence of risk factors related to NAFLD + increased ALT – symptomatic liver disease +/- hepatomegaly, +/- increased ALT – homeostasis model assessment-insulin resistance HOMA IR score > 3 – presence of liver steatosis or stiffness measured by transient elastography – eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI>27 kg/m2) serum cholesterol of > 200 mg/d Patients were excluded from the study if showing evidence : Exclusion Criteria:

  • if showing evidence of alcoholic or chronic liver disease – Hepatocellular Carcinoma, autoimmune hepatitis – end stage liver disease – treatment with other hepatoprotectants – other concomitant EPL within 30 days of study initiation – pregnancy or lactation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nehal Abou Seada
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nehal Abou Seada, Principal Investigator – Ain Shams University

References

National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.

European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.

Chalasani N; Writing Group for American Association for Study of Liver Diseases; American College of Gastroenterology; American Gastroenterology Association practice guideline on Diagnosis and Management of Nonalcoholic Fatty Liver Disease. Reply: To PMID 22488764. Hepatology. 2013 Feb;57(2):853-4. doi: 10.1002/hep.26199. Epub 2013 Jan 7. No abstract available.

Ahmed MH, Noor SK, Bushara SO, Husain NE, Elmadhoun WM, Ginawi IA, Osman MM, Mahmoud AO, Almobarak AO. Non-Alcoholic Fatty Liver Disease in Africa and Middle East: An Attempt to Predict the Present and Future Implications on the Healthcare System. Gastroenterology Res. 2017 Oct;10(5):271-279. doi: 10.14740/gr913w. Epub 2017 Oct 26.

Citations Reporting on Results

Gundermann KJ, Gundermann S, Drozdzik M, Mohan Prasad VG. Essential phospholipids in fatty liver: a scientific update. Clin Exp Gastroenterol. 2016 May 5;9:105-17. doi: 10.2147/CEG.S96362. eCollection 2016.

Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

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