RecruitingPhase 2NCT06477146

Milk Thistle Clinical Trial in Pediatric NAFLD

Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)

Sponsor

University Hospitals Cleveland Medical Center

Enrollment

20 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Non-alcoholic Fatty Liver Disease NAFLD

Summary

Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.

Eligibility

Min Age: 9 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fibroscan, a behavioral approach called Lifestyle Modification, and others for people with non-alcoholic fatty liver disease nafld. The study is currently recruiting participants at 1 location. People eligible for this study include aged 9 Years to 22 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMilk 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.

DRUGPlacebo

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

BEHAVIORALLifestyle 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.

DEVICEFibroscan

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.