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[Among studies available to clarify the hypolipidemic effect of encapsulated DHA(docosahexaenoic acid, C22:6 n−3)and EPA(eicosapentaenoic acid, C20:5 n−3), a clinical trial of consuming fish sausage enriched with DHA 850 mg, and EPA 200 mg proved to lower serum triglyceride. These findings permitted the sausage to be marketed as a special health food(a food for a specified health use)in Japan. In the present study, DHA and EPA mixed into fish hamburger were fed to subjects for three months to assess those hypolipidemic activity. Evaluation of safety was performed in a human study based on consuming 3 times the recommended amount. In a randomized double−blinded placebo−controlled trial, serum triglyceride values in the 8th and 12th weeks were significantly lowered in subjects who consumed the enriched fish hamburger. In the 12th week, remnant−like particle(RLP)cholesterol, which is associated with coronary heart disease, was also lowered compared with that in the placebo group. A month−long safety evaluation of excessive intake revealed no adverse effects. Thus, this fish hamburger appeared to be useful for preventing the regression of lifestyle−related diseases, and for promoting general human health. (Jpn Pharmacol Ther 2008;36:333−45)KEY WORDS DHA, EPA, Fish hamburger, Triglyceride, RLP−cholesterol, Safety, Among studies available to clarify the hypolipidemic effect of encapsulated DHA(docosahexaenoic acid, C22:6 n−3)and EPA(eicosapentaenoic acid, C20:5 n−3), a clinical trial of consuming fish sausage enriched with DHA 850 mg, and EPA 200 mg proved to lower serum triglyceride. These findings permitted the sausage to be marketed as a special health food(a food for a specified health use)in Japan. In the present study, DHA and EPA mixed into fish hamburger were fed to subjects for three months to assess those hypolipidemic activity. Evaluation of safety was performed in a human study based on consuming 3 times the recommended amount. In a randomized double−blinded placebo−controlled trial, serum triglyceride values in the 8th and 12th weeks were significantly lowered in subjects who consumed the enriched fish hamburger. In the 12th week, remnant−like particle(RLP)cholesterol, which is associated with coronary heart disease, was also lowered compared with that in the placebo group. A month−long safety evaluation of excessive intake revealed no adverse effects. Thus, this fish hamburger appeared to be useful for preventing the regression of lifestyle−related diseases, and for promoting general human health. (Jpn Pharmacol Ther 2008;36:333−45)KEY WORDS DHA, EPA, Fish hamburger, Triglyceride, RLP−cholesterol, Safety]
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