Hepaxa Management of Non-alcoholic Fatty Liver Disease



Status:Not yet recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:February 2019
End Date:December 2019

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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

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.

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.

Inclusion Criteria:

1. Men or women, ≥18 years of age.

2. Suspicion of NAFLD

3. Able to understand and cooperate with study procedures, and have signed a written
informed consent prior to any study procedures.

4. CAP score at -6 months and at inclusion of >268

5. A fibroscan elastography score <9 Kpa (Advanced Fibrosis)

Exclusion Criteria:

1. 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.

2. Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within
six months of screening.

3. Individuals taking prescription or supplemental omega-3 fatty acids.

4. 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.
We found this trial at
1
site
2510 Lakeland Drive
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
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