Functional Foods and Clinical Trial

ABSTRACT

There have been no specific health claims for functional foods. So, a lot of namely functional foods have been produced, and consumers confuse these functional foods with conventional foods. Last year, the Chonbuk National University Hospital established a clinical trial center for functional foods to meet the social needs for the validation of functional foods. For a successful clinical trial for functional foods, their characteristics should be understood. The followings should be considered before clinical trial (1) The clinical trial for functional foods is different from that for pharmaceuticals, since the subjects for the functional foods should be healthy and sub-healthy persons, not patients. (2) Some clinical trials for functional foods should be done in a larger pool of subjects because functional foods show less significant effects compared to medical agents. (3) The diet should be more tightly regulated for clinical trial of functional foods. (4) Appropriate biomarkers are required for clinical trials for functional foods.