Currently, self-medication, including the use of foods with health claims (FHCs), is promoted as means of increasing our health span. However, the functional substance(s) in FHCs and its actions are diverse, and therefore it is difficult to evaluate their safety and efficacy in clinical trials. In this review article, we describe the definition and the history of regulations regarding FHCs. After discussing their types and features, we explain the differences on regulations between FHCs and ethical pharmaceuticals regarding their safety and efficacy in clinical trials, which are required to provide them with scientific evidence. Finally, we believe that transparent standards regarding the evaluation of FHCs would help increase the use of FHCs and their market value in the future.

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Objective: We examined anti-influenza virus (anti-IFV) activity of Coix-seed Reactive Derivatives (CRD) extract. Methods: H1N1 A/Puerto Rico/8/34 (PR8) strain was infected to Malin Darby Canine Kidney (MDCK) cells. The infected cells were cultured by medium supplemented CRD extract for 24 h, and the supernatants were harvested to analyze virus titer by focus-forming reduction assay. Polyphenols were removed by PVPP treatment, and anti-influenza virus activity was compared with normal CRD extract. Results: CRD extract showed anti-IFV activity. In addition, CRD extract inhibited viral adsorption and replication. The study of CRD extract by PVPP treatment suggested that polyphenols are the main active component. Conclusion: This study revealed that CRD extract has anti-IFV activity against PR8 strain. The mechanism of action was inhibited viral adsorption and replication. It was also suggested that anti-IFV activity of CRD extract is due to polyphenols.

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Objective: Red Koji (red yeast rice), which has been shown to reduce serum LDL cholesterol levels, has potential as a material in the development of functional food. The efficacy and safety of fermented food generally depends on the production method (including bacterial strains, bacterial species, and incubation conditions); therefore, it is important to confirm the safety of materials individually. Design: We conducted a randomized, double-blind placebo-controlled clinical study to investigate the safety of red yeast rice (3P-D21) produced by the solid state fermentation of the Monascus pilosus KP1148 strain. Fifty-one healthy volunteers with normal cholesterol levels and borderline and mild hypercholesterolemia were divided into 2 groups: one group given the test food [500 mg of red yeast rice (2.0 mg as monascin)] for 4 weeks, and the other a placebo food. Safety was evaluated using blood and urine analyses, a physical examination, and medical interviews. Results: No adverse events were associated with the intake of the test food in any examinations. Conclusion: These results show that food containing 500 mg of red yeast rice (2.0 mg as monascin) is safe, and red yeast rice produced by the solid state fermentation of the Monascus pilosus KP1148 strain has potential as a material in the development of functional food.

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Objective: To show the preventive effect of Brazilian propolis on metabolic syndrome. Methods: Nine Brazilian propolis were examined for inhibition ofα-glucosidase, absorption of sugar in mice, and lipid accumulation, glycerol 3-phosphate dehydrogenase, and adiponection production in mouse 3T3-L1 cells. Results: In nine Brazilian propolis, AF-06, AF-19, and AFG-06 propolis inhibited rat internal α-glucosidase, and AF-06 propolis inhibited the absorption of sugar in mice. In 3T3-L1 cells, AF-06 and AF-08 propolis inhibited accumulation lipid, and inhibited glycerol 3-phosphate dehydrogenase. Conclusion: Brazilian propolis AF-06 and AF-08 are natural products which offer promise in the prevention of diabetes and metabolic syndrome. Incorporating dietary supplements into a treatment plan with medicines with similar effects requires further study.

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We previously reported that treatment with tricin (4’,5,7-trihydroxy-3’,5’-dimethoxyflavone) after human cytomegalovirus (HCMV) infection significantly suppressed both infectious virus production and HCMV replication in human embryonic lung fibroblast (HEL) cells. Moreover, we recently revealed that HCMV infection can increase the expression of CC-motif ligand 2 (CCL2/MCP-1) and CCR2, a specific receptor for CCL2, which can enhance HCMV infection and replication, in turn. In this study, we examined whether CCL2 and/or CCR2 are involved in the anti-HCMV effects of tricin in HEL cells. Exposure of fibroblasts to tricin inhibited infectious HCMV production, with concomitant decreases in CCL2 and CCR2 transcript levels and CCL2 protein levels in a dose-dependent manner. Propagermanium, an inhibitor of CCR2 function, has also been shown to inhibit infectious HCMV production with concomitant decreases in CCL2 protein levels. We further observed that tricin and propagermanium reduced mRNA expression of HCMV immediate early gene and DNA polymerase in a dose-dependent manner. These results suggest that tricin is a novel anti-inflammatory compound with potential anti-HCMV activity, and CCL2/CCR2 interactions are associated with HCMV replication.

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