NCT05499585

Treating Pediatric NAFLD with Nutrition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.

Detailed description

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD. This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Liver Diseases
• Liver Fat
• Hepatic Steatosis
• Nutritional and Metabolic Disease

Interventions

Type	Name	Description
OTHER	Whole Dairy	2 1/2 servings of whole dairy per day

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-08-15
• Completion: 2024-09-10
• First posted: 2022-08-12
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States