2.2.9. Safety Assessments
diarrhea
For safety assessments, participants received a doctor’s consultation, and subjective and objective symptoms were determined in a screening test and at 0, 6, and 12 weeks after the start of intake. Body weight (body mass index), blood pressure, and pulse were measured simultaneously. Hematological parameters (hemoglobin, hematocrit, white and red blood cell counts, and blood platelets), biochemical parameters (total protein, albumin, total bilirubin, aspartate aminotransferase, alanine transaminase, lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transpeptidase, glucose, hemoglobin A1c, sodium, potassium, chloride, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, blood urea nitrogen, and uric acid), and urinalysis parameters (urobilinogen [qualitative], bilirubin [qualitative], protein [qualitative], glucose [qualitative], ketones, occult blood, and pH) in the participants’ blood and urine samples were measured in the screening tests and at 0 and 12 weeks after starting intake. These measurements were performed by LSI Medience Corporation (Tokyo, Japan).The participants were instructed to maintain a daily record during the pre-observation and intake periods. The records covered defecation, diarrhea, menstruation, medication use, outings, test sample consumption, and physical condition.