Efficacy of Phosphatidylcholine in NAFLD

June 1, 2020 updated by: Nehal Abou Seada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • Health education
  • Behavior therapy
Active Comparator: Control Group
50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist
Behavioral: Lifestyle modification
Lifestyle modification and health education by Clinical Pharmacist
Other Names:
  • Health education
  • Behavior therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, at 3 and 6 month
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
baseline , at 3 and 6 month
change from baseline Lipid Profile
Time Frame: baseline , at 3 and 6 month
Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein
baseline , at 3 and 6 month
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
baseline , at 3 and 6 month
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.
baseline , at 3 and 6 month
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
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
Time Frame: baseline , at 3 and 6 month
platelet count
baseline , at 3 and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nehal Abou Seada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2016

Primary Completion (Actual)

January 3, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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