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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
2.1 g Phosphatidylcholine daily in addition to lifestyle modification
Lifestyle modification and health education by Clinical Pharmacist
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).
Time frame: 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
Time frame: baseline , at 3 and 6 month
change from baseline Lipid Profile
Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein
Time frame: baseline , at 3 and 6 month
change from baseline Oxidative stress markers
malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay
Time frame: 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.
Time frame: 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
Time frame: baseline , at 3 and 6 month
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change from baseline Complete Blood Picture at 3 and 6 month
platelet count
Time frame: baseline , at 3 and 6 month