Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)

Inclusion Criteria

• •1. Age above 21 years, male or female.
• •2. Estimated average alcohol consumption \< 30 g/d for men or \< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
• •1. Clinical suspicion of NAFLD, defined by a liver biopsy result consistent with NAFLD or the presence of at least two of the following criteria:
• •1. Suggestion of liver fat by an imaging study (ultrasound, CT scan, MRI or MR spectroscopy) performed in the 6 months prior to enrollment.
• •2. Elevated aminotransferase levels (ALT \> 31 U/L for men or \> 19 U/L for women, or AST \> 30 U/L) on at least two occasions in the 6 months preceding enrollment.
• •3. Presence of the metabolic syndrome, defined according to the modified AHA/NCEP criteria30 as the presence of at least three of:
• •* Abdominal obesity, defined as waist circumference \> 102 cm for men or \> 88 cm for women
• •* Elevated triglycerides (\> 150 mg/dL) or the use of medication to lower triglycerides
• •* Reduced HDL cholesterol (\< 40 mg/DL for men or \< 50 mg/dL for women)
• •* Elevated blood pressure (\> 135/80 mmHg) or use of medication for hypertension
• •* Elevated fasting glucose levels (\> 100 mg/dL) or use of antidiabetic medication
• •For the purpose of inclusion, the presence of overt diabetes mellitus type 2 will be considered equivalent to the presence of the metabolic syndrome, even if the other criteria are absent.
• •2. Enrolled in 13-DK-0002
• •or
• •3. Non-alcoholic liver disease subjects treated off-protocol with lifestyle intervention or vitamin E treatment.
• •1. Evidence of metabolic syndrome as defined in NAFLD criterion 1.c.
• •2. Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to19 U/L for women, or AST less than or equal to 30 U/L) at screening
• •3. Absence of liver fat by imaging or liver biopsy within 6 months of screening with no (or trace) liver fat
• •1. No history of known liver disease
• •2. Not on any regular systemic medications (with the exception of oral contraceptives)
• •3. BMI less than or equal to 25 kg/m2
• •4. Non diabetic
• •5. Normal ALT and fasting glucose
• •9. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
• •10. Diabetic patients requiring insulin treatment
• •11. Milk or soy protein allergy
• •12. Uncontrolled hypo/hyperthyroidism