Hepaxa Management of Non-alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03801577
• Other study ID #: CTN01019401
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: BASF AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NASH - Nonalcoholic Steatohepatitis
• Non Alcoholic Fatty Liver
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Hepaxa
High concentrate EPA and DHA

Locations

Country	Name	City	State
United States	GI Associates and Endoscopy Center	Flowood	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
BASF AS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome. Stratification of effect Hepaxa using FLI score	The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa	6 months
Primary	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	Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study	Blood test	6 months
Secondary	Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study	Blood test	6 months
Secondary	Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study	Blood test	6 months
Secondary	Change in Level of plasma triglycerides from baseline to end of study	Blood test	6 months
Secondary	Change in weight from baseline to end of study	Blood test	6 months