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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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Secretory immunoglobulin A (s-IgA) in saliva constitutes the first-line barrier to the entry of pathogens into the body, implying its critical role in mucosal immunity.To examine the effect of a shark liver oil (SLO)-containing diet on salivary s-IgA concentration in healthy male and female adults, 42 subjects were assigned to either placebo or 6 weeks of a 2,400 mg SLO-containing diet (1,500 mg as SLO) and assessed in a randomized, double-blind, placebo-controlled, parallel group trial.Salivary s-IgA concentration significantly increased at week 6 in the SLO group (P = 0.033), but not in the placebo group.Moreover, there was a significant difference between groups in the magnitude of change from baseline to week 6.No intervention-related adverse event or abnormal changes of laboratory test parameters were observed throughout the study period.In conclusion, an SLO-containing diet increases salivary s-IgA in healthy adults.
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<b>Objectives</b>: The present study was examined the effects of dietary supplement containing Kurozu concentrate on Blood Pressure, QOL and Traditional Chinese Medicine (TCM) Constitution. <b>Methods</b>: Forty subjects with slightly high blood pressure were assigned randomly to 2 groups (active group and placebo group). Kurozu-containing foods or the placebo was administered to the subjects daily for 12 weeks. At week 0, 6 and 12, blood samples were collected, physical measurements were taken, and the quality of life (SF-36v2) and TCM constitution were examined. <b>Results</b>: Significant differences on blood pressure and TCM constitution between the groups were observed at week 12. The change of QOL between the groups was observed significantly at week 6. <b>Conclusion</b>: These findings suggest that foods containing Kurozu have hypotensive action and improve effects on constitutional problems. In addition, it was confirmed that foods containing Kurozu are safe to ingest.
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<b>Objectives:</b> To examine in two tests the potential of kaki (persimmon) extract-containing diet (KE diet) to reduce malodorous volatile sulfur compounds (VSC), such as hydrogen sulfide (H<sub>2</sub>S), methyl mercaptan (CH<sub>3</sub>SH) and dimethyl sulfide (CH<sub>3</sub>SCH<sub>3</sub>), as well as on subjective fecal odor on healthy adults.<br> <b>Methods:</b> In the first test, 11 subjects were given garlic-containing soup. For a period of time, they were given a single dose of KE diet (150 mg as kaki extract) with water, and only water for the rest of the study period. Two hours after the administration, oral gas samples were collected from individual subjects and analyzed for VSC. In the second test, 14 subjects were given a single dose of KE diet for 7 days. Fecal samples were collected from individual subjects before and after the 7-day KE diet intervention. Levels of VSC were determined and the magnitude of subjective fecal odor was estimated based on ratings in the self-administered questionnaire.<br> <b>Results:</b> Levels of CH<sub>3</sub>SCH<sub>3</sub> in oral gas were significantly lowered when subjects were on a KE diet. On the other hand, although decreases in the level of any VSC in feces before and after the 7-day KE diet intake did not reach a statistical significance, subjective fecal odor significantly improved by the KE diet intake.<br> <b>Conclusion:</b> KE diet appears to have a beneficial effect on VSC-associated oral malodor and subjective fecal odor.<br>
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<b>Objectives:</b> Kurozu has long been used as a traditional fermented food product mainly in East Asia, including Japan; various health functions of Kurozu have been reported. This study examined its effects on body fat and energy metabolism by a double-blind placebo-controlled trial.<br> <b>Methods:</b> Mildly obese adults took a dietary supplement containing Kurozu concentrate for 12 weeks with approximately 10 min of exercise every day.<br> <b>Results:</b> A decline in hip circumference was observed in the group consuming the dietary supplement containing Kurozu. It was shown that fat-derived energy consumption increased while suppressing carbohydrate-derived energy consumption. Therefore, it was revealed that energy was derived from the fat consumed, and a tendency to increase the energy consumption at the time of exercise was also observed. Furthermore, negative correlations were observed between the initial fat volume and both the variation of the total fat area and the variation of the subcutaneous fat area in the examination group. It was revealed that larger the amount of body fat, greater the effect of Kurozu in decreasing the amount of fat. In addition, no safety issues were observed 12 weeks after ingesting the dietary supplement containing Kurozu concentrate, and it was confirmed as a safe food product.<br> <b>Conclusion:</b> Appropriate exercise and intake of the dietary supplement containing Kurozu concentrate contributed toward the improvement of the metabolic syndrome.<br>