Statistical analysis
muscle soreness, ®, fatigue
ADVERSE EVENTS
Efficacy and safety were evaluated using the per-protocol set (PPS) and the full analysis set (FAS), respectively (See A mixed model analysis of variance with group and time was used for muscle soreness VAS, fatigue VAS, muscle strength, ROM, and blood levels of CPK and LDH. Because of the non-normal distribution, the values of CPK and LDH were log-transformed. When the mixed model analysis indicated a significant interaction effect, Sidak’s multiple comparison test analyzed paired values between the test food groups at each time point, followed by the determination of the 95% confidence interval (CI) of the mean difference and effect size. When the mixed model analysis indicated a time effect, Dunnett’s test analyzed the repeated values. Because of the crossover trial, significant inter-group differences were valid in the case of neither carryover effects nor period effects (See The baseline characteristics of participants were compared between the prior-test food groups using t-tests. For intake rate of test food, BDHQ, and SF-8 surveys, as well as physical & physiological and blood tests, paired t-tests compared values between the test food groups. As for the intra-group comparison, paired t-tests were used for blood tests and the SF-8 survey, and repeated Dunnett’s test for physical & physiological tests. The incidence of adverse events and side effects were analyzed using Fisher’s exact test. All data are shown as means ± SD.The significance level was 5% with a two-tailed test. Microsoft Excel (Microsoft Corp., Redmond, WA, USA) was used for tabulation and graphing, and IBM® SPSS 26.0 (IBM Japan, Tokyo, Japan), Microsoft Excel, and GraphPad Prism 6 (GraphPad Software, San Diego, CA, USA) were used for statistical analyses.In this trial, the effect size for muscle soreness was assumed to be 0.8 based on the previous study [