Dietary Treatment Study of Pediatric NAFLD

Not Applicable

Completed

Conditions: Nonalcoholic Fatty Liver Disease

Interventions: Other: Dietary modification

Registration Number: NCT02513121

Lead Sponsor: University of California, San Diego

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 40

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
Neutrophil count < 1,500 cells/mm3 of blood
Platelets < 130,000 cells/mm3 of blood
Direct bilirubin > 1.0 mg/dL
Total bilirubin > 3 mg/dL
Albumin < 3.2 g/dL
International normalized ratio (INR) > 1.4
Evidence of other chronic liver disease
Children who are currently enrolled in a clinical trial or who received an investigational study drug or a medication with the intent to treat NAFLD/NASH in the past 60 days
Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices, aneurysm clips, pacemaker, cochlear implants
Unable to have or complete the MRI exam due to body weight exceeding scanner table limit or girth exceeding scanner bore diameter
Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
Families with > 5 individuals
Failure to give informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary modification	Dietary modification	Low free sugar diet

Primary Outcome Measures

Name	Time	Method
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group	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 Outcome Measures

Name	Time	Method
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	HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Change in Triglycerides From Baseline to Week 8	Measurements done at baseline and week 8