Milk Thistle Clinical Trial in Pediatric NAFLD

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Non-Alcoholic Fatty Liver Disease (NAFLD)
Interventions
DRUG

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.

DRUG

Placebo

The placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition.

BEHAVIORAL

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."

DEVICE

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.

Trial Locations (1)

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
lead

University Hospitals Cleveland Medical Center

OTHER