Evaluation of Health-promoting Function by Clinical Trials of New Functional Foods

Abstract

After the introduction of Food for Specified Health Uses system in 1991, circumstances in which functions of foods are evaluated by clinical trials, are improving. Issues of clinical trials of foods in Japan are discussed in comparing with drug cases. Necessity of the addition of systems ensuring the reliability of data is suggested in clinical trial practices of food cases. Some differences of endpoints between drugs and foods are pointed out, and needs of experts who explain medical meanings of such differences to consumers are discussed. In the case of evaluation of disease risk reduction, large scale clinical trials are needed, and then financial supports by government are needed.