Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT06113003
Eligibility Criteria:
Inclusion Criteria:
* One of the following:
1. One or more of the components of metabolic syndrome, defined as:
1. Diagnosis of diabetes: on medication for diabetes for at least 6 months, HbA1c \>6.5%, or fasting glucose \>99 mg/dL
2. Elevated fasting triglycerides: \>149 mg/dL or on medication for dyslipidemia
3. Reduced HDL-C: \<40 mg/dL in males, \<50 mg/dL in females or on medication for dyslipidemia
4. Elevated blood pressure: \>129 mm Hg systolic and/or \>84 mm Hg diastolic or on medication for hypertension
5. 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
2. 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
3. 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
Exclusion Criteria:
* Not fluent in English
* Known allergy to the study product or its formulation
* Pregnant or planning to become pregnant within the next six months
* History of chronic diarrhea in the past three months
* Breastfeeding
* History of celiac disease
* 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
* 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
* AUDIT-C score ≥3 women and ≥4 in men
* History of inflammatory bowel disease
* History of all other GI surgery within the past 12 months
* Use of antibiotics in the past 30 days
* Metal shrapnel, MRI incompatible hardware or claustrophobia that would preclude MRI imaging
* Inability to participate in the study in the opinion of the participant's HIV treatment provider
* Use of prebiotic(s) including fiber supplements and/or probiotic(s) within the past 90 days
* Participant has history of hemicolectomy, colectomy, small bowel resection, bariatric surgery, gastric bypass surgery, or short bowel syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT06113003
Study Brief:
Protocol Section:
NCT06113003