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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
University of California, San Diego
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
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.
Time frame: Measurements done at baseline and week 8.
Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Time frame: Measurements doen at baseline and week 8
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Insulin From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Time frame: Measurements done at baseline and week 8
Change in Triglycerides From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
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