薬理と治療

Abstract

Objectives We carried out two double︱blind, placebo︱controlled, parallel group studies to evaluate the safety of long︱term intake and excessive intake of the biscuits containing highly cross︱linked starch（HXLS）from tapioca. Methods For long︱term intake study and excessive intake study, 24 healthy volunteer subjects were randomly divided into two groups, respectively. In the long︱term intake study, subjects ingested one package（28 g）of the test biscuits containing 7 g（as fiber）of HXLS or the same amount of the placebo biscuits without HXLS per day for 12 weeks. In the excessive intake study, subjects ingested one package（47g）of the test biscuits containing 21 g（as fiber）of HXLS, which is triple amount of long -term study, or the same amount of the placebo biscuits per day for 4 weeks. Results No unusual changes were observed in physical, blood, urinary examination and medical interview on HXLS containing biscuits in the long︱term intake study and the excessive intake study. Conclusion These results suggest that the biscuits containing HXLS was safe for both long-term and excessive intake.