Efficacy of Phosphatidylcholine in NAFLD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Phosphatidyl Choline
* Behavioral: Lifestyle modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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 | Dietary Supplement: Phosphatidyl Choline<br>* 2.1 g Phosphatidylcholine daily in addition to lifestyle modification<br>Behavioral: Lifestyle modification<br>* Lifestyle modification and health education by Clinical Pharmacist<br>* Other names: Health education;|
| Active Comparator: Control Group<br>50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist | Behavioral: Lifestyle modification<br>* Lifestyle modification and health education by Clinical Pharmacist<br>* Other names: Health education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Body Mass Index (BMI) at 3 and 6 month | person's weight in kilograms divided by the square of the person's height in metres (kg/m2). | baseline, at 3 and 6 month | 
| change from baseline liver stiffness 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 | baseline , at 3 and 6 month | 
| change from baseline Lipid Profile | Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein | baseline , at 3 and 6 month | 
| change from baseline Oxidative stress markers | malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay | baseline , at 3 and 6 month | 
| change from baseline NAFLD score 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. | baseline , at 3 and 6 month | 
| change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month | HOMA IR scores <3 normal HOMA IR scores >5 severe insulin resistance 3 to 5 moderate insulin resistance | baseline , at 3 and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Complete Blood Picture at 3 and 6 month | platelet count | baseline , at 3 and 6 month |