Hepaxa Management of Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.

Detailed Description
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Subjects With fatty liver are given Hepaxa for 6 months. Fibroscan CAP measurements are taken at 3 monthly intervals. Subjects consent to Collection of data from approximately 6 months prior to use of Hepaxa. Patients unresponsive to life style recommendations given as standard practice will be enrolled.

Official Title
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Hepaxa Management of Non-Alcoholic Fatty Liver Disease (NAFLD): A Real-world Pilot Study Observing Effects of Nutritional Management With Hepaxa in Subjects With Liver Steatosis

Conditions
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Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Dietary Supplement: Hepaxa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, ≥18 years of age. Suspicion of NAFLD Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures. CAP score at -6 months and at inclusion of >268 A fibroscan elastography score <9 Kpa (Advanced Fibrosis) Exclusion Criteria: Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic. Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within six months of screening. Individuals taking prescription or supplemental omega-3 fatty acids. Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects are screened for eligibility and on consent, historical data from liver fat measurements With CAP scores, will be collected from the previous 6 months. Only subjects With no, or poor response to lifestyle recommendations will be enrolled.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepaxa<br>Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period) | Dietary Supplement: Hepaxa<br>* High concentrate EPA and DHA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in liver fat content (hepatic steatosis) from baseline to end of study | Liver fat will be measured using the Controlled Attenuation Parameter from the ultrasound based Fibroscan machine | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study | Blood test | 6 months | 
| Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study | Blood test | 6 months | 
| Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study | Blood test | 6 months | 
| Change in Level of plasma triglycerides from baseline to end of study | Blood test | 6 months | 
| Change in weight from baseline to end of study | Blood test | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3, nafld, nafl, nash, medical food