Prevention of NAFLD in Hispanic Children

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title: Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children

Status Recruiting

Clinical Trial Summary

This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.

Clinical Trial Description

The number of children experiencing obesity and the chronic diseases associated with it have risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk with which they were born. Excess fat in the liver increases the risk of diabetes and heart disease as well the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increases children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels, reduces the amount of fat stored in the liver and improves the metabolic health of children with NAFLD.

This single site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increase in risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children age 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent is performed by members of the research team. The one-year dietary intervention, will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low-free sugar diet for the entire family, and nutritionist guided (and study funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments, and compensation.

The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, incidence of NAFLD in the intervention group vs. control group will be assessed (primary outcome of 24 month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition and metabolomics.

These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

• NCT number: NCT05292352
• Study type: Interventional
• Source: Emory University
• Contact: Miriam Vos, MD
• Phone: 404-727-9930
• Email: mvos@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Completion date: June 2026