J Korean Med Assoc.  2005 Jun;48(6):517-522.

Functional Foods and Clinical Trial

• Chae SW

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.

Keyword

Functional food; Clinical trial; Diet

MeSH Terms

Biomarkers
Diet
Functional Food*
Humans
Jeollabuk-do

Reference

3. Guide to Clinical Trials(Bert Spilker).

4. Principles and Practice of Clinical Research (John I Gallin).

5. Introduction to Clinical Trials.

6. Fundamentaes of Clinical Trials' 3rd.