Dietary Treatment Study of Pediatric NAFLD

Inclusion Criteria:

- Boys age 11-16 years inclusive.

- Clinical history consistent with NAFLD.

- Biopsy-proven NAFLD

- MRI measured Liver Proton Density Fat Fraction ≥10%

- ALT ≥ 45 u/L

- No evidence of any other liver disease by clinical history or histological evaluation.

- Written informed consent from parent or legal guardian.

- Written informed assent from the child or adolescent.

Exclusion Criteria:

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current
history of the following conditions or any other health issues that make it unsafe for them
to participate in the opinion of the Investigators will be excluded from the study:

- History of significant alcohol intake (AUDIT questionnaire) or inability to quantify
alcohol consumption

- Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic
steatosis or steatohepatitis in the past year.

- The use of other known hepatotoxins within 120 days of baseline

- History of total parenteral nutrition (TPN) use in the year prior to screening

- History of bariatric surgery or planning to undergo bariatric surgery during the study
duration

- Significant depression

- Non-compensated liver disease with any one of the following hematologic, biochemical,
and serological criteria on entry into protocol:

- Hemoglobin < 10 g/dL

- White blood cell < 3,500 cells/mm

- Neutrophil count < 1,500 cells/mm3 of blood

- Platelets < 130,000 cells/mm3 of blood

- Direct bilirubin > 1.0 mg/dL

- Total bilirubin > 3 mg/dL

- Albumin < 3.2 g/dL

- International normalized ratio (INR) > 1.4

- Evidence of other chronic liver disease

- Children who are currently enrolled in a clinical trial or who received an
investigational study drug or a medication with the intent to treat NAFLD/NASH in the
past 60 days

- Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices,
aneurysm clips, pacemaker, cochlear implants

- Unable to have or complete the MRI exam due to body weight exceeding scanner table
limit or girth exceeding scanner bore diameter

- Subjects who are not able or willing to comply with the protocol or have any other
condition that would impede compliance or hinder completion of the study, in the
opinion of the investigator

- Families with > 5 individuals

- Failure to give informed consent