Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients

Subjects with non-alcoholic fatty liver (simple steatosis) confirmed within the last year by
ultrasound or other imaging modality will be recruited to the study. Subjects will be
randomized to a treatment arm of high concentrate capsules or placebo for a 6 month treatment
period.Omega-3 content of red blood cells (omega-3 index) will be measured for primary
endpoint assessment. Quantitative MRI will be performed to determine the effect on liver fat
content.

Inclusion Criteria:

1. Documented history of clinical diagnosis of NAFLD by ultrasound, MRI or biopsy within
one (1) year prior to screening (V1). If the diagnostic test date is greater than one
(1) year, abdominal ultrasound will be repeated at (V1) and must confirm a diagnosis
of NAFLD.

2. Men or women, ≥18 years of age.

3. BMI between 18.0 and 39.9 kg/m2.

4. Non-smokers (>3 months of non-smoking).

5. If on a statin regimen, history (> 1 month stable dose) of taking a statin medication
(HMG-CoA reductase inhibitor example: Lipitor, Zocor, Crestor, Pravachol, Lescol,
Livalo, etc).

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

Exclusion Criteria:

1. Diagnosis of NASH.

2. Bilirubin >2x ULN.

3. 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.

4. Subjects with a history of bariatric surgery.

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

6. Current or recent (within six months of screening) history of significant
gastrointestinal, renal, pulmonary, hepatic or biliary disease, endocrine diseases or
other invasive weight loss treatments (Type II Diabetes permitted, and stable (> 3
months) thyroid disorders).

7. Individual taking prescription or over-the-counter medications (including dietary
supplements, see Appendix 1) known to alter lipid metabolism, within four (4) weeks of
randomization. These medications include (but are not limited to) the following: bile
acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates,

8. Individuals taking prescription omega-3 fatty acids.

9. Use of supplements including Omega-3s and Omega-6s, other oil-based supplements,
phytosterols, Vitamin E, prebiotics and probiotics, or any weight loss supplements
within four (4) weeks of randomization (multivitamins and minerals containing Vitamin
E are permitted).

10. Use of systemic corticosteroids, androgens (except androgens for hypogonadism to
restore normal levels), phenytoin, erythromycin and other macrolides,
thiazolidinediones (e.g. pioglitazone), and thyroid hormones (except stable-dose
thyroid replacement therapy for four (4) weeks prior to enrollment).

11. Use of the anticoagulants warfarin (Coumadin), dabigatran (Pradaxa), apixaban
(Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are
allowed.

12. Pregnant or lactating women or women of childbearing potential, who are not using an
approved method of contraception. A woman is considered to be of childbearing
potential unless she is post-hysterectomy, one or more years postmenopausal, or one or
more years post-tubal ligation.

13. History of significant cardiovascular or coronary heart disease (CVD or CHD) as
defined by having had a coronary artery bypass procedure, coronary stent or
angioplasty, or myocardial infarction in the previous six (6) months.

14. History of cancer, other than non-melanoma skin cancer and basal cell carcinoma,
within the previous five years.

15. Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mmHg
and/or diastolic blood pressure ≥95 mmHg).

16. Recent history of prolonged alcohol (>3 months) use (within past 6 months) or
excessive alcohol use, defined as >14 drinks per week (one drink = 12 oz. beer, 4 oz.
wine, 1.5 oz. hard liquor).

17. Exposure to any investigational agent within four (4) weeks prior to Visit 1.

18. Subjects planning to undergo surgery during the study period or up to 1 month after
the study

19. Any serious psychiatric disease or disorder, which, in the opinion of the
investigator, would preclude the subject from participating in the study.

20. Any known intolerance to the investigational ingredients of this medical food.

21. 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.