Milk Thistle Clinical Trial in Pediatric 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.

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  lead OTHER

Principal Investigators

• Thomas Sferra, MD · University Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-19

Primary Completion

2029-01-31

Completion

2029-01-31

FDA Drug

Yes

Countries

• United States

Study Locations