薬理と治療

Abstract

Objective　To investigate the effects of consumption of konjac processed food （KPF） on defecation in subjects who defecate three to five times per week. Methods　Thirty-three Japanese subjects who defecate three to five times per week participated in a randomized, double-blind, placebo-controlled study between March and October 2017. The subjects were randomly allocated to group A（one pack of KPF daily, n＝11）, group B（two packs of KPF daily, n＝11）, or a placebo group（one pack of placebo daily, n＝11） using a computerized random-number generator. All subjects consumed their assigned food every day for four weeks. The effects on defecation were assessed based on defecation frequency, shape of stool, smell of stool, subjective symptoms of constipation（CAS-MT）, bacterial flora analysis（T-RFLP）, and Bristol stool chart. A safety evaluation was also performed. Results　The outcomes of the subjects in groups A（n＝7）, B（n＝8）, and placebo（n＝7） were analyzed using per-protocol set. With respect to the bowel movement diary, group A showed significant increase in defecation days（P＝0.027, P＝0.025, respectively）and defecation frequency（P＝0.032, P＝0.029, respectively）at 4 weeks and Δ4 weeks compared with those of group B. No adverse effects were reported regarding the test food. Conclusions　Consumption of KPF for 4 weeks increased the frequency of defecation in subjects who defecate three to five times per week, suggesting that KPF improves defecation in people with constipation. Trial registration　UMIN-CTR UMIN000027836 Foundation　ORIHIRO PLANTDEW Co., Ltd.