Current status of health-related clinical evaluation outcome: Overview of systematic literature reviews for improvement of intestinal environment health claim category

Abstract

• 89.7% of FFCs used stool frequency as a clinical evaluation outcome. • The factor to lead the use of stool frequency was supplement shape as food form. • Status of evaluation indicators for a function claim needs re-assessment. • International trade restrictions could be reduced by standardized guidelines. This study used systematic literature reviews conducted in Japan of a finished product or functional ingredient to identify foods with function claims. We used “stool frequency” as the benchmark for the health claim of “improvement of the intestinal environment.” We found 427 foods with function claims, 384 (89.9%) foods with function claims used “stool frequency.” We identified “supplement shape” (OR: 4.62; 95% CI [1.90, 11.20]) as a significant factor in the use of “stool frequency.” Our findings suggest that both supplements and using another shape as a food form could ensure real benefits for consumers by incorporating health-related outcomes.