Sample size was calculated based on change in HTGC from previous data in NAFLD12 (link); an 80% power of detecting a 10% relative difference between group change in liver HTGC with a SD of 9.0 and a 1-sided 0.05 significance required n = 11 per group. We recruited 13 per sample to allow 2 drop-outs per group. Normality was assessed using a Kolmogorov–Smirnov test and logarithmically transformed if not normally distributed. Between-group differences were evaluated using an unpaired t test and within-group differences using a paired t test (2 way). Treatment Ă— time interactions were assessed using a 2-way analysis of variance. Analyses of covariance were used to test for between-group differences in outcome variables while controlling for baseline values. Bivariate correlations using Pearson rank correlations were conducted to investigate any associations between HTGC, body composition, triglyceride levels, glucose control, biomarkers of inflammation, and NAFLD fibrosis marking systems. Statistical significance was set at a P value of less than .05. Statistical analyses were performed using SPSS statistical analysis software (version 19; IBM, Chicago, Illinois). All authors had access to the study data and reviewed and approved the final manuscript.
Free full text: Click here