The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease

Prior treatment

• Prior diagnosis of non-NAFLD liver disease including, but not limited to, Wilson Disease, hemochromatosis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, and alpha 1 antitrypsin deficiency

Other illness

• Known allergy to the study product or its formulation
• History of chronic diarrhea in the past three months
• History of celiac disease
• On medications associated with secondary NAFLD including systemic corticosteroids, tamoxifen, methotrexate, nifedipine, history of cancer chemotherapy,
• Positive hepatitis C quant or on treatment for hepatitis C within the last 12 months
• History of cirrhosis or liver transplant
• History of inflammatory bowel disease
• History of all other GI surgery within the past 12 months
• Inability to participate in the study in the opinion of the participant's HIV treatment provider
• Participant has history of hemicolectomy, colectomy, small bowel resection, bariatric surgery, gastric bypass surgery, or short bowel syndrome

Other

• Not fluent in English
• Pregnant or planning to become pregnant within the next six months
• Breastfeeding
• AUDIT-C score ≥3 women and ≥4 in men
• Use of antibiotics in the past 30 days
• Metal shrapnel, MRI incompatible hardware or claustrophobia that would preclude MRI imaging
• Use of prebiotic(s) including fiber supplements and/or probiotic(s) within the past 90 days

• One of the following:
  • One or more of the components of metabolic syndrome, defined as:
  • Diagnosis of diabetes: on medication for diabetes for at least 6 months, HbA1c \>6.5%, or fasting glucose \>99 mg/dL
  • Elevated fasting triglycerides: \>149 mg/dL or on medication for dyslipidemia
  • Reduced HDL-C: \<40 mg/dL in males, \<50 mg/dL in females or on medication for dyslipidemia
  • Elevated blood pressure: \>129 mm Hg systolic and/or \>84 mm Hg diastolic or on medication for hypertension
  • Prior diagnosis of hepatic steatosis or NAFLD: hepatic steatosis noted on interpretation of clinical imaging, CT scan liver density of less than 58 HU, Fibroscan CAP score \>238 dB/m, MRI-PDFF ≥5%, liver biopsy showing ≥5% triglyceride content
  • Persistently abnormal transaminases: elevated liver enzymes defined by transaminases ≥1.5 upper limit of normal (\[ULN\] = 35 IU/mL) and/or gammaglutamyltransferase level ≥2 ULN (ULN = 60 IU/L) on 2 blood samples within at least a 3-month interval
  • BMI ≥ 30 kg/m2
• Documented HIV infection
• On antiretroviral therapy for at least 18 months
• HIV-1 RNA \<50 copies/ml for the prior 12 months
• CD4 count \>350 cells/microliter for the prior 12 months
• Ability to be contacted by phone (home or cell)
• Access to a private (i.e. accessible only to participant and immediate family or roommates) refrigerator for 6 months
• Able and willing to comply with all study protocols and procedures