Clinical trial NCT03801577: Hepaxa Management of Non-alcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non Alcoholic Fatty Liver
NASH - Nonalcoholic Steatohepatitis
Keywords: omega-3
nafld
nafl
nash
medical food
Lead sponsor: BASF AS
Sponsor class: INDUSTRY
First posted: 2019-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in liver fat content (hepatic steatosis) from baseline to end of study
timeFrame: 6 months
Secondary outcomes:
measure: Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
timeFrame: 6 months
measure: Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
timeFrame: 6 months
measure: Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
timeFrame: 6 months
measure: Change in Level of plasma triglycerides from baseline to end of study
timeFrame: 6 months
measure: Change in weight from baseline to end of study
timeFrame: 6 months
Other outcomes:
measure: Exploratory outcome. Stratification of effect Hepaxa using FLI score
timeFrame: 6 months
Locations:
city: Flowood
country: United States
facility: GI Associates and Endoscopy Center
state: Mississippi
Study officials:
affiliation: GI Associates and Endoscopy Center
name: Reed Hogan, MD
role: PRINCIPAL_INVESTIGATOR
References: