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The present study is the first to report the hypocholesterolemic effect of chitosan on humans. When 3-6 g/day of chitosan was given in the diet to 8 healthy males, total serum cholesterol significantly decreased, and when the ingestion was stopped, the value increased to the level before ingestion. Serum HDL-cholesterol was increased significantly by the ingestion of chitosan. The excreted amounts of primary bile acids, cholic acid and chenodeoxycholic acid, into the feces was significantly increased by the ingestion of chitosan, and the amount of cholic acid excretion decreased significantly after the ingestion was stopped. These facts suggest that chitosan combined bile acids in the digestive tract, and that the combined product was excreted into the feces. This, in turn, deceased the resorption of bile acids, so that the cholesterol poool in the body was decreased and the level of serum chrolesterol consequently decreased.Chitin is a polysaccharide contained in the cuticle of Crustacea and insects, and in the cell walls of some kinds of mold. Chitosan is the general name for the dilute acid-soluble group of deacetylated chitin. The chemical structure of chitosan is similar to that of cellulose in dietary fiber. Chitosan is not hydrolyzable by the digestive enzymes in humans, so it can be classed as one of the dietary fibers of animal origin. However, it is a cationic polymer having an amino group in its chemical structure, which is a characteristic greatly different from those of other dietary fibers.Many functions of chitosan attributable to its amino group are known. Among them, the most noticeable is its hypocholesterolemic effect,l -6) and several studies on its mechanism have been reported. 5, 7) According to these reports, it has been said that chitosan is .dissolved in the digestive tract under acidic conditions, combines bile acid with its ion-exchanging function, and excretes the combined bile acid outside the body; consequently, it decreases the cholesterol pool in the body. However, all of these studies on the hypocholesterolemic effect of chitosan so far reported have used animals,1-6) and there is no report on a study of the effects on humans. Moreover, data for elucidating the mechanism were obtained mostly by in vitro studies,7) and the proposed mechanism based upon animal studies is not entirely clear.The present study is the first to report the hypocholesterolemic effect of chitosan on humans. The results obtained are particularly useful for the effect of chitosan on the metabolism of serum cholesterol and its possible mechanism of action.. Materials and MethodsTest subjects. This study was performed in conformity with the spirit of the "Declaration of Helsinki". The test subjects were 8 healthy male volunteers between 20 and 23 years of age, who were informed of the details of the aims, contents and methods of the study, and after giving their consent, decided to participate in the study of their own free will. All of them were university studuents, and Table I shows the background factors f...

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Lactosucrose (4G-B-D-galactosylsucrose) was fermented in vitro by bifidobacteria and lactobacilli, and to a limited degree by the Bacteroides fragilis group, clostridia, eubacteria, and enterobacteriaceae. The effects of dietary lactosucrose on the fecal flora and fecal metabolites were studied in eight healthy volunteers (20-23 years of age) who ingested 3 g of lactosucrose/day for 7 days followed by 6 g of lactosucrose/day for 7 consecutive days. During lactosucrose intake, the counts of bifidobacteria were increased significantly (p< 0.001), whereas the counts of clostridia, including Clostridium perfringens, and bacteroidaceae were decreased significantly (p<0.05) compared with the values before the intake. The total bacterial counts were decreased significantly (p< 0.05) on day 14 during the intake. The frequency of occurrence of lecithinase-negative clostridia was decreased significantly (p<0.05) when compared with the values before and after the intake. No detectable changes occurred in the counts of other organisms throughout the experimental periods. Fecal concentrations of ammonia, sulfide, phenol, ethylphenol, skatol and indole were decreased significantly (p< 0.05) during lactosucrose intake. Acetic acid and lactic acid were increased significantly (p< 0.05) during the intake. Fecal enzyme activity of B-glucuronidase was decreased significantly (p< 0.05) on day 14 of the intake. Serum very low density lipoprotein (VLDL) was increased significantly (p< 0.01) on day 14 during the intake. Mean fecal pH values decreased from 6.3 to 5.9, and mean water content increased 3.6% during the intake. Fecal weight was increased slightly during the intake. The results obtained showed that the effective dose of lactosucrose for all healthy adults is 3 g/day.