Healthy Eating Through Reduction Of Excess Sugar
Condition: NAFLD
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of dietary sugar reduction in obese
      children and examine whether there are differential effects based on genotype of a single
      amino acid substitution in the PNPLA3 gene that is highly prevalent in Hispanics and
      associated with significantly elevated liver fat.
    

Detailed description: 
      This dietary intervention aims at developing a more personalized and targeted treatment for
      NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The
      investigators previous publications have shown that this particular demographic has a greater
      than 2-fold higher liver fat compared to GC and CC individuals. They have also demonstrated a
      significant gene*dietary sugar interaction with a significant association between liver fat
      and dietary sugar intake in GG subjects with no such association in GC or CC individuals.
      These studies suggests that different dietary strategies may have differential effects on
      reducing liver fat, depending on PNPLA3 genotype. To confirm this, the investigators will
      complete a clinical trial in 120 overweight and obese Hispanic children (12 - 18 years) with
      clinically verified NAFLD who will be randomized to one of two 12-week interventions:

      Group 1 (standard of care control group): Dietary intervention focused on healthy eating
      (n=60; 30GG + 30GC/CC)

      Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating
      and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal
      of 10% of daily calories (n=60; 30GG + 30GC/CC)

      The following outcomes will be measured before and after intervention: Total liver fat
      fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic resonance
      imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body fat by
      DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and inflammatory
      markers, gut microbiome, and insulin and glucose response to an oral glucose challenge. The
      investigators hypothesize that liver fat fraction, liver fibrosis, and metabolic outcomes,
      such as fasting and 2h-glucose and insulin, and inflammatory biomarkers, will show
      significantly greater improvements with sugar reduction relative to control. In addition, the
      investigators also hypothesize a treatment*genotype interaction whereby the reduction in
      liver fat will be significantly greater in GG relative to CC/CG subjects.
    

Intervention name(s): Standard of care plus sugar-reduction education
Intervention type(s): Other
Intervention description(s): This is a 12-week intervention where subjects will be educated on how to monitor their added sugar consumption. They will be asked to eliminate consumption of sweetened beverages for the 12-week period and will be receiving a weekly delivery of water bottles to their homes to displace the sweetened beverages in their home environment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obesity; fatty liver; sugar; PNPLA3