Hepaxa Management of Non-alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-12-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepaxa

Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)

Group Type EXPERIMENTAL

Hepaxa

Intervention Type DIETARY_SUPPLEMENT

High concentrate EPA and DHA

Interventions

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Hepaxa

High concentrate EPA and DHA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No