Abstract
Authors have already reported that administration of 1200mg/day of Chitosan (twice a daily three capsules at each time) significantly reduced serum total cholesterol (p=0.04) compared with placebo group in a double blind manner for 2 months without concomitant diet therapy. This study was investigated efficacy and safety in the case that 1.200mg of Chitosan in the capsulated form was consecutively administrated to the subjects after double blind test without washout term and concomitant diet therapy under the informed consent. Reduction of total serum cholesterol was observed significantly in two (n=30) and four (n=35) month's treatment (p=0.0014, p=0.0025) respectively by repeated-measure ANOVA. In the group with the values beyond the maximum of reference value of total cholesterol before chitosan treatment, the mean relative change of cholesterol [(base line-after treatment)/base line] decreased about 5% by administration for two months or more. On the other hand it almost unchanged in the group with the values within the reference value of total cholesterol. Chitosan has been approved as specific food additive for hyperlipidemia up to now. In the present experiments, capsulated chitosan was shown to have anti-hyperlipidemia activity as well as that used as food additive. Adverse food additive reactions (AFAR) were observed as 2 affairs (1 case) in the 2-month group and 5 affairs (4 cases) in the 4-month group. Over-all frequency of AFAR was 7.7%(5/65) and AFAR with highest frequency was 4.6%(3165) in thirsty. Over load study using three times of the amount described above (3600mg/day) did not show serious AFAR and adsorption of vitamin E for 14 consecutive days. In conclusion, 1200mg/day of capsulated chitosan was confirmed to have efficacy and have no severe AFAR in four month's administration study and its over load test. Usual dose of capsulated chitosan was considered safety as well as the food additive.
