Sample size calculations were carried out in PASS 15.0.5 software (NCSS, Kaysville, UT, USA) based on the data from Properzi et al. (26 (link)). To find an expected difference of 25% in MAFLD remission between groups after the 12-week intervention, considering a significance level of 5%, power of at least 80%, and allowing for 10% dropout, the study aimed to recruit 60 subjects. At least 27 subjects from each dietary group were required to detect diet-induced differences.
The case report form (CRF) was strictly reviewed by the quality control team and entered into the management system after confirmation. All follow-up data were recorded and time checked before being entered into the system.
At the end of the study, endpoints were analyzed based on the intention-to-treat method. IBM SPSS Statistical Analysis Software for Windows, version 23.0, was used for statistical analysis. After baseline values were adjusted, differences in macronutrient and clinical indicator outcomes between groups were examined using repeated measures analysis of covariance (ANCOVA). The Fisher's permutation test was used to assess the independence of the main outcome of this trial. Paired t-tests or nonparametric Wilcoxon signed-rank tests were used to analyze statistical differences within groups. The significance was determined using a p-value threshold of 0.05.
The case report form (CRF) was strictly reviewed by the quality control team and entered into the management system after confirmation. All follow-up data were recorded and time checked before being entered into the system.
At the end of the study, endpoints were analyzed based on the intention-to-treat method. IBM SPSS Statistical Analysis Software for Windows, version 23.0, was used for statistical analysis. After baseline values were adjusted, differences in macronutrient and clinical indicator outcomes between groups were examined using repeated measures analysis of covariance (ANCOVA). The Fisher's permutation test was used to assess the independence of the main outcome of this trial. Paired t-tests or nonparametric Wilcoxon signed-rank tests were used to analyze statistical differences within groups. The significance was determined using a p-value threshold of 0.05.