Treating Pediatric NAFLD With Nutrition

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Nutritional and Metabolic Disease; Liver Diseases; Hepatic Steatosis; Liver Fat
• Interventions: Other: Whole Dairy

• Registration Number: NCT05499585
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2022-09-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-04
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm One	Whole Dairy	Habitual diet for 12 weeks followed by experimental diet for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in hepatic steatosis measured by liver MRI-PDFF	Baseline to 12 weeks and 12 weeks to 24 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States