Treating Pediatric NAFLD with Nutrition

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Fat; Hepatic Steatosis; Non-Alcoholic Fatty Liver Disease; Nutritional and Metabolic Disease
• Intervention / Treatment: Other: Whole Dairy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm One; Habitual diet for 12 weeks followed by experimental diet for 12 weeks	Other: Whole Dairy; 2 1/2 servings of whole dairy per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hepatic steatosis measured by liver MRI-PDFF	The primary outcome for the 24 week study is to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD	Baseline to 12 weeks and 12 weeks to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum alanine transaminase (ALT)	ALT will be measured and compared	Baseline, week 12 and week 24
Change in serum aspartate transaminase (AST)	AST will be measured and compared	Baseline, week 12 and week 24
Change in serum gamma-glutamyl transpeptidase (GGT)	GGT will be measured and compared	Baseline, week 12 and week 24
Change in serum total cholesterol	Serum total cholesterol will be measured and compared	Baseline, week 12 and week 24
Change in serum LDL-cholesterol	Serum LDL-cholesterol will be measured and compared	Baseline, week 12 and week 24
Change in serum HDL-cholesterol	Serum HDL-cholesterol will be measured and compared	Baseline, week 12 and week 24
Change in serum triglycerides	Serum triglycerides will be measured and compared	Baseline, week 12 and week 24
Change in plasma fatty acid levels	Plasma fatty acid levels will be measured and compared	Baseline, week 12 and week 24
Change in subcutaneous adipose tissue (SCAT)	SCAT will be measured and compared	Baseline, week 12 and week 24
Change in visceral adipose tissue (VAT)	VAT will be measured and compared	Baseline, week 12 and week 24

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Jeffrey Schwimmer, MD, UC San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: adolescent; nutrition; child; liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Diseases
• Other Study ID Numbers: 803602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No