2.4. Outcomes
SECONDARY
The measured values of the total score of JKOM at 12 weeks after the test sample consumption were considered the primary outcome of this study. The secondary outcomes were as follows: (1) the measured values of the total score of JKOM at 4 and 8 weeks after consumption; (2) the differences in the total score of JKOM between screening (0 weeks) and 4, 8, or 12 weeks; (3) the measured values at 4, 8, and 12 weeks and amounts of changes between screening (0 weeks) and 4, 8, or 12 weeks after assessment of VAS [The JKOM questionnaire was written in Japanese and an English translation had been published [Diets three days before each test date were surveyed. The diet study used the Calorie and Nutrition Diary (CAND), developed by Ortho Medico [