Treating Pediatric NAFLD With Nutrition

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

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, we will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. We will then instruct children 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 we will measure liver fat with MR once again. We will also measure labs to assess safety and further evaluate the liver

Interventions

  • Other: Nutrition
    • 2 1/2 servings of whole dairy per day

Arms, Groups and Cohorts

  • Other: Arm One
    • Habitual diet for 12 weeks followed by experimental diet for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in hepatic steatosis measured by liver MRI-PDFF
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey B. Schwimmer, MD, MD – University of California, San Diego
  • Overall Official(s)
    • Jeffrey Schwimmer, MD, Principal Investigator, UC San Diego
  • Overall Contact(s)
    • Patricia A Ugalde Nicalo, 619.543.7673, pugaldenicalo@health.ucsd.edu

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