Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liver disease in adolescents with obesity: Trial design and methodology

In this two-arm, parallel design randomized controlled trial (RCT), 40 participants aged 9 to 18 years were randomized to a CHO restricted diet (<25:>50:25% daily calories from CHO: fat: protein) or control, fat restricted diet (55,20:25% daily calories from CHO: fat: protein). This family-based diet intervention included: (1) a 2-week supply of groceries to feed a four-person household specific to the assigned diet; and (2) extensive education on diet implementation through biweekly, diet-specific group and individualized counseling sessions with participants and one parent or guardian led by a registered dietitian (RD). The primary outcome measure of this study was hepatic lipid, measured using magnetic resonance spectroscopy (MRS). Secondary outcomes included liver transaminases; markers of inflammation (hsCRP, IL-6, TNF-α); body composition; visceral adipose tissue; and insulin resistance. All testing was conducted at baseline and week 8; hepatic transaminases were also measured at weeks 2 and 4. This RCT is registered with ClinicalTrials.gov (ID: NCT02787668).