Drug Discov Ther. 2021;15(1):9-13. (DOI: 10.5582/ddt.2021.01018)
A digital scheme of human trials for the evaluation of functional foods
Miyashita A, Shimomura K, Nakajima H, Matsumoto Y, Sekimizu K
In this study, we designed a method for conducting a human study by the following process. (1) The host computer stores the subject information. (2) The sample preparer prepares a food sample. (3) The subject (healthy human volunteer) sends the information of an intake of the food sample to the host computer, which creates an event entry for the event. (4) The medical professional (typically a physician) collects and stores the subject's blood sample in a container with the subject's identification (e.g., ID number). (5) The sample analyst analyzes the blood biochemical profiles. (6) The host computer stores the blood biochemical data, and by matching the blood biochemical data with the subject IDs, a final analysis report will automatically be created. In this study, we also run a test case, based on this design, where we obtained a blood biochemical dataset from healthy volunteers. This scheme can reduce the cost of human trials for functional foods and will help acquiring the scientific basis of functional foods.