Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nonalcoholic Fatty Liver Disease
- Sponsor
- University of California, San Diego
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU). The purpose of this study is to understand the potential of a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be assessed using advanced magnetic resonance imaging (MRI) testing to measure liver fat.
Investigators
Jeffrey B. Schwimmer, MD
Professor of Pediatrics
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •Boys age 11-16 years inclusive.
- •Clinical history consistent with NAFLD.
- •Biopsy-proven NAFLD
- •MRI measured Liver Proton Density Fat Fraction ≥10%
- •alanine aminotransferase (ALT) ≥ 45 u/L
- •No evidence of any other liver disease by clinical history or histological evaluation.
- •Written informed consent from parent or legal guardian.
- •Written informed assent from the child or adolescent.
Exclusion Criteria
- •Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:
- •History of significant alcohol intake (Alcohol Use Disorders Identification Test \[AUDIT\]) or inability to quantify alcohol consumption
- •Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
- •The use of other known hepatotoxins within 120 days of baseline
- •History of total parenteral nutrition (TPN) use in the year prior to screening
- •History of bariatric surgery or planning to undergo bariatric surgery during the study duration
- •Significant depression
- •Non-compensated liver disease with any one of the following hematologic, biochemical, and serological criteria on entry into protocol:
- •Hemoglobin \< 10 g/dL
- •White blood cell \< 3,500 cells/mm
Outcomes
Primary Outcomes
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Time Frame: Measurements done at baseline and week 8.
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (\<3%) in boys with NAFLD will change liver fat % measured by MRI.
Secondary Outcomes
- Change in Alanine Aminotransferase (ALT) From Baseline to Week 8(Measurements done at baseline and week 8)
- Change in Aspartate Aminotransferase (AST) From Baseline to Week 8(Measurements doen at baseline and week 8)
- Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8(Measurements done at baseline and week 8)
- Change in Insulin From Baseline to Week 8(Measurements done at baseline and week 8)
- Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8(Measurements done at baseline and week 8)
- Change in Triglycerides From Baseline to Week 8(Measurements done at baseline and week 8)