Efficacy of Phosphatidylcholine in NAFLD

NCT04411862 | Completed Phase 3 DMC

• 1 other identifier: NAFLD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• change from baseline Complete Blood Picture at 3 and 6 month

  baseline , at 3 and 6 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Behavioral: Lifestyle modification

Control Group

ACTIVE COMPARATOR

50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist

Behavioral: Lifestyle modification

Interventions

Phosphatidyl Choline DIETARY_SUPPLEMENT

2.1 g Phosphatidylcholine daily in addition to lifestyle modification

Intervention Group

Lifestyle modification BEHAVIORAL

Lifestyle modification and health education by Clinical Pharmacist

Also known as: Behavior therapy, Health education

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :

You may not qualify if:

• 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

Sponsors & Collaborators

• Nehal Abou Seada: lead

Related Publications (6)

• 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.

  PMID: 12485966 BACKGROUND

• 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.

  PMID: 27062661 BACKGROUND

• 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.

  PMID: 23297154 BACKGROUND

• 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.

  PMID: 29118867 BACKGROUND

• 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.

  PMID: 27217791 RESULT

• 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.

  PMID: 28714183 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Phosphatidylcholines; Behavior Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: June 2, 2020
• Study Start: January 2, 2016
• Primary Completion: January 3, 2019
• Study Completion: July 1, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06