Efficacy of Phosphatidylcholine in NAFLD

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411862
• Other study ID #: NAFLD
• Status: Completed
• Phase: Phase 3
• Start date: January 2, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nehal Abou Seada

References & Publications (6)

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. Review. — View Citation

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. Hepatol — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	change from baseline Lipid Profile	Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein	baseline , at 3 and 6 month
Primary	change from baseline Oxidative stress markers	malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay	baseline , at 3 and 6 month
Primary	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
Primary	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	change from baseline Complete Blood Picture at 3 and 6 month	platelet count	baseline , at 3 and 6 month