2.3. Participants
allergic, malignant tumor, Depression, allergic reactions, Fatigue
MALIGNANT TUMOR, REMISSION, ALLERGIC REACTION
Two hundred fifty-one potential participants were informed verbally and documentarily of this study and signed an informed consent form before participation. These candidates went through the following pre-examination sessions. In total, 76 subjects who were healthy and eligible to participate in this study based on the results of the pre-examinations participated in this clinical trial. The eligibility criteria were (1) those who were healthy adults 20–64 years of age and (2) those who scored higher than 50 on the Profile of Mood Status 2nd edition short form for adults (POMS 2) Fatigue–Inertia subscale and less than 50 on the POMS 2 Vigor–Activity subscale at least once in the two pre-examinations. Participants were excluded if they met the following exclusion criteria: (1) those who were under medical treatment due to mental health issues and/or tested positive on a Major Depression Episode Sheet, (2) those who were on night shift or whose lifestyle was day–night reversed, or who went to bed from 6:00 a.m. to 10:00 a.m. and woke up from 6:00 p.m. to 8:00 p.m. at least once per week, (3) those who habitually consumed energy drinks more than once a week, (4) those who saw a doctor, were under medical treatment, or who took medicines/supplements in order to reduce stress and/or improve sleep quality, (5) those who were allergic to or had shown allergic reactions to certain allergens, (6) those with a medical condition that required chronic drug administration or who had a history of malignant tumor that required drug administration except for those who were diagnosed as being in remission, (7) those whose hematology test and vital sign assessment results were categorized as worse than group D, as defined by the Japan Society of NINGEN Dock, (8) those who were currently attending another clinical trial, (9) those who planned to become pregnant or to breastfeed during the study period, and (10) those who the principal investigator decided were unable to undergo the investigations and/or observe the patient restrictions. Seventy-six participants who satisfied the criteria listed above were enrolled in this study and were randomly allocated to the REP hydrolysate arm (