https://www.ncbi.nlm.nih.gov/pubmed/29601997

Contemp Clin Trials. 2018 Mar 27. pii: S1551-7144(17)30601-8. doi: 10.1016/j.cct.2018.03.014. [Epub ahead of print]

Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liverdisease in adolescents with obesity: Trial design and methodology.
Dowla S, Pendergrass M, Bolding M, Gower B, Fontaine K, Ashraf A, Soleymani T, Morrison S, Goss A.

Abstract

BACKGROUND:

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder among children in the developed world and can progress to cirrhosis, hepatocellular carcinoma, and liver failure. No evidence-based dietary guidelines exist on the most effective diet prescription to treat NAFLD.

OBJECTIVE:
To compare the effect of a carbohydrate (CHO)-restricted diet vs fat-restricted diet, the current standard of care, on changes in hepatic fat infiltration, body composition, and metabolic health over an 8-week period among overweight and obese children diagnosed with NAFLD.

METHODS:
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).