The Clinical Safety Test of the Intake of Coix-seed Reactive Derivatives (CRD) in Healthy Adult Volunteers

Objective: In this study, we evaluated the safety of intake of Coix-seed Reactive Derivatives (CRD) in healthy adult volunteers.Methods: Eight subjects (4 males and 4 females, ages 26.6 ± 4.7) consumed 2.0g CRD/day for 4weeks. We observed weight, vital signs(blood pressure, pulse, body temperature), complete blood count(red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, white blood cell count, and platelet count), hemogram, blood chemistry(Na, K, Cl, AST, ALT, γ-GTP, LDH, ALP, total protein, albumin, A/G, total bilirubin, urea nitrogen, creatinine, cholinesterase, total cholesterol, HDL cholesterol, LDL cholesterol, and neutral fats), coagulation examination (prothrombin time and partial prothrombin time), and urinalysis (sugar, protein, and occult blood in urine).Results: Although several laboratory data (MCHC, MCV and serum creatinine) changed slightly, all of these values were within normal range. Furthermore, no severe adverse effect was observed. Conclusion: These results suggest that CRD intake up to 2g/day is safe in healthy adults. Further study will be needed to define the safety of long-term administration of CRD.