2.7. Outcome Measurement
BLOOD
The safety and potential efficacy of coffee cherry pulp juice concentrate compared to a placebo was assessed using body weight, vital signs (blood pressure and pulse rate), and clinical laboratory tests including fasting plasma glucose (FPG), liver function (aspartate transaminase (AST), alanine aminotransferase (ALT), and total bilirubin), renal function (blood urea nitrogen (BUN) and creatinine (CR), lipid profile (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total triglycerides), complete blood count (CBC), urinalysis tests, and electrocardiograms (EKGs). Throughout the study, adverse symptoms were recorded by the participants in subject diaries, and participants were interviewed by a researcher at every follow-up visit. Body weight was determined using a bioelectrical impedance machine, TANITA BC-730 (Tanita Corporation, Tokyo, Japan). Blood pressure and pulse rate were measured using a Digital Blood Pressure Monitor OMRON HEM-7156A (OMRON HEALTHCARE Co., Ltd., Kyoto, Japan). Electrocardiograms (EKG) were measured using a portable ECG monitor Contec PM10 (Contec Medical Systems Co., Ltd., Qinhuangdao, Hebei, China). FBS, AST, ALT, BUN, CR, and lipid profile were measured using a semi-automatic biochemistry analyzer Layto RT9200 (Rayto Life and Analytical Sciences Co., Ltd., Shenzhen, China). CBC was measured using a Sysmex XN-10™ Automated Hematology Analyzer (Sysmex Corporation, Kobe, Japan).