Efficacy of Phosphatidylcholine in NAFLD

Nehal Abou Seada

Status and phase: Completed; Phase 3

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Lifestyle modification; Dietary Supplement: Phosphatidyl Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT04411862

NAFLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle modification

Dietary Supplement: Phosphatidyl Choline

Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle modification