Authors have already reported that administrationof 1200 mg/day of chitosan (twice a daily three capsules at eachtime) significantly reduced serum total cholesterol (p=0.04)compared with placebo group in a double blind manner for 2 monthswithout concomitant diet therapy. This study was investigatedef'ficacy and safety in the case that 1 200 mg of chitosan in thecapsulated form was consecutively administrated to the subjectsafter double blind test without washout term and concomitant diettherapy under the informed consent. Reduction of total serumcholesterol was observed significantly in two (n=30) and four(n=35) month's treatment (p=0.0014, p=0.0025) respectively byrepeated-measure ANOVA. In the group with the values beyond themaximum of reference value of total cholesterol before chitosantreatment, the mean relative change of cholesterol [(baseline-after treatment)/base line] decreased about 5% byadministration for two months or more. On the other hand it almostunchanged in the group with the values within the reference valueof total cholesterol. Chitosan has been approved as specific foodadditive for hyperlipidemia up to now. In the present experiments,capsulated chitosan was shown to have anti-hyperlipidemia activityas well as that used as food additive. Adverse food additivereactions (AFAR) were observed as 2 affairs (1 case) in the 2-monthgroup and 5 affairs (4 cases) in the 4-month group. Over-allfrequency of AFAR was 7.7%(5/65) and AFAR with highest frequencywas 4.6%(3/65) in thirsty. Over loa, d study using three times ofthe amount described above (3600 mg/day) did not show serious AFARand adsorption of vitamin E for 14 consecutive days. In conclusion,1200 mg/day of capsulated chitosan was confirmed to have efficacyand have no severe AFAR in four month's administration study andits over load test. Usual dose of capsulated chitosan wasconsidered safety as well as the food additive.
Key words: chitosan, capsule, safety, efficacy, Iong-term,cholesterol, human |
