Treating Pediatric NAFLD with Nutrition

NCT ID: NCT05499585

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2024-09-10

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm One

Habitual diet for 12 weeks followed by experimental diet for 12 weeks

Group Type: OTHER

Whole Dairy

Intervention Type: OTHER

2 1/2 servings of whole dairy per day

Interventions

Whole Dairy

2 1/2 servings of whole dairy per day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 10 through 17 years
• NAFLD
• ALT of ≥ 40 U/L
• MRI-PDFF ≥ 8%
• Ability and willingness of legal guardian and participant to provide written, informed consent

Exclusion Criteria

Competing Health Conditions

• Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator
• Type 1 or Type 2 Diabetes
• LDL-cholesterol > 160 mg/dL
• Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease)
• History of bariatric surgery or planning to undergo bariatric surgery during the study duration
• Participant with a history of conditions affecting digestion and/or absorption

Intervention

• Inability or refusal to consume dairy
• Cow's milk protein allergy
• Lactose intolerance

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey B. Schwimmer, MD

Principal Investigator, Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Schwimmer, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

803602

Identifier Type: -

Identifier Source: org_study_id