20
Participants
Start Date
December 19, 2024
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Milk thistle (MT)
MT capsules will contain 300 mg of MT with 80% content of Silymarin, standardized to 240mg Silymarin content. Dosing will be based on body weight with maximum dose of 600 mg/day. Dosing will be either 1 or 2 capsules per day based on weight.
Placebo
The placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition.
Lifestyle Modification
"The primary instructions for lifestyle modification are:~1. Physical activity goal- 20-30 minutes per day 5 to 7 days per week. The aim is 150 minutes a week and more than 300 calories burnt for each workout.~2. Adequate hydration- 4-5 bottles of water a day.~3. Limitation of sugar-free beverages- once daily and 1-2 (8 oz) cups of skim/1% milk (or dairy alternative) daily.~4. Avoidance of beverages with added sugar such as soda, Kool-Aid, juice, and Gatorade.~5. Ideal consumption- three meals daily(breakfast, lunch, dinner)and one snack.~6. Snack Goal \<200 calories. If a 2nd, 3rd, etc. snack is desired it will only be a vegetable.~7. Five servings of fruits/vegetables per day.~8. Each food we recommend eating should have dietary fiber \>3 grams/serving. Ideally \>5 grams/serving.~9. The given survival guide will have all information regarding serving size and portion allotment.~10. MyPlate.gov handout given which will guide participants in relation to portion control."
Fibroscan
FibroScan will be completed to measure Elastography. Elastography works by emitting small pulse of energy which may be perceived as a vibration which quickly calculated the stiffness of the liver, which correlates to fat deposition and fibrosis.
RECRUITING
University Hospitals Cleveland Medical Center, Cleveland
University Hospitals Cleveland Medical Center
OTHER