2.6. Diet Survey and Safety Evaluation
TG
ADVERSE EVENTS, EVENTS, BLOOD
The food frequency questionnaire (FFQ) was used to assess dietary and nutrient intake. Safety was assessed using diary records, medical interviews, general blood tests, and physical examinations. All adverse events (AEs) and side effects were monitored in participants who took the test tablets at least once, and the incidence of these events was calculated. Blood pressure, pulse rate, and body weight were measured at every visit, whereas body height was measured only at the first visit. Blood samples for general biochemical examinations were obtained in a fasting state at each visit and were measured for the following items at Sapporo Clinical Laboratory Inc. (Sapporo, Japan): white blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), platelet count (Plt), and hematocrit (Ht) for complete blood count test; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) for lipid panel tests; fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) for blood glucose profile test; creatinine (CRE), uric acid (UA), and blood urea nitrogen (BUN) for renal function assessment; and gamma-glutamyl transpeptidase (γ-GTP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase (ALP) for liver function assessment. A medical interview was conducted by a clinical physician at every visit.