ガラクトオリゴ糖液糖の最大無作用量推定と安全性評価

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タイトル別名
  • Evaluating the Laxative Threshold and Safety of Galactooligosaccharide Syrup
  • ガラクト オリゴトウエキ トウ ノ サイダイ ムサヨウリョウ スイテイ ト アンゼンセイ ヒョウカ

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To estimate the laxative threshold (LT) and 50% effective dose (ED50) for diarrhea of a galactooligosaccharide (GOS) syrup (43% GOS ; 9.5% lactose ; 18% glucose ; 6.3% galactose ; 24% water), we asked 24 healthy subjects (12 men and 12 women ; age, 20 to 58 years ; weight, 39.0 to 96.0 kg) to ingest 190mL of aqueous solutions containing 5 different amounts (11.7,23.3,46.7, 70.0, 93.3g) of the syrup once every week from a low content to high one. Of the 24 subjects, 16 had diarrhea after ingestion of any test beverage. We estimeted the LT and ED50 of the GOS syrup by using a regression equation between the minimal dose levels (g/kg body weght) of the syrup caused diarrhea and the cumulative incidence of diarrhea. For the entire population, the estimated LT was 0.68 g/kg (0.30 g/kg as GOS) and the ED50 was 1.39 g/kg (0.60 g/kg as GOS). For men, the LT and ED50 were 0.65 g/kg and 1.13 g/kg, respectively, as compared with 0.90 g/kg and 1.50 g/kg for women. An increased frequency of bowel movements seemed to increase the incidence of diarrhea. The other abdominal symptoms reported were borborygmus (88%), flatus (58%), and abdominal distention (46%), all of which were transient, as was diarrhea. We also examined the safety of ingesting daily near amount of LT of the GOS syrup (15 g/person daily as GOS) for 2 weeks in 20 healthy adults. Although this dose increased the occurrence of abdominal gas in these subjects, the prevalence of diarrhea was unchanged as compared with that for the placebo beverage. These results show that the GOS syrup is safe even in repeated intake for near amount of LT.

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