About this trial
Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection.
Two phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.
Eligibility criteria
Qualifiers
Regular consumption of alcohol with an intake of >60 g daily or >420 g weekly on average for men and >40 g daily or >280 g weekly on average for women for 6 months or more
MELD <21
Serum total bilirubin >3 mg/dL
AST >50 IU/I; AST:ALT ratio >1.5; Both AST and ALT <400 IU/I
Disqualifiers
Pregnant or breastfeeding women
Patients with gastrointestinal bleeding within 2 weeks
Active infection (positive blood or ascitic fluid culture)
Overt encephalopathy
Trial design
Treatments tested in this trial
- Sodium Hyaluronate
- Placebo