2.10. Sample Size
In Trial 1, referring to previous studies that evaluated the effects of food components on memory function, the number of participants for per protocol set (PPS) analysis was set at 30 in each group, which is the number required for an exploratory study of the effect on memory function. Based on a 25% dropout rate, it was calculated that 40 participants were necessary for each group.In Trial 2, referring to the results of Trial 1, the number of participants for PPS analysis was set at 79 in each group, which is the number required for a confirmatory study. Based on an 18% dropout rate, it was calculated that 96 participants were necessary for each group. The 79 participants in each group provided a statistical power of 80% at a 5% significance level for analyses to detect differences between groups.