NASH - Nonalcoholic Steatohepatitis, Non Alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
omega-3, nafld, nafl, nash, medical food
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.
Interventions
DIETARY_SUPPLEMENTHepaxa
High concentrate EPA and DHA
Sponsors
BASF AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in liver fat content (hepatic steatosis) from baseline to end of study | 6 months | Liver fat will be measured using the Controlled Attenuation Parameter from the ultrasound based Fibroscan machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study | 6 months | Blood test |
| Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study | 6 months | Blood test |
| Change in Level of plasma triglycerides from baseline to end of study | 6 months | Blood test |
| Change in weight from baseline to end of study | 6 months | Blood test |
| Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study | 6 months | Blood test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcome. Stratification of effect Hepaxa using FLI score | 6 months | The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa |
Countries
United States
Outcome results
None listed