Safety Assessment of Excessive Intake of Vinegar Drink Supplemented with Xylooligosaccharide in Normal Volunteers

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  • MIURA Katsuyuki
    Departments of Applied Pharmacology and Therapeutics, Osaka City University Medical School
  • NAKAO Takafumi
    Pharmacology, Osaka City University Medical School Center for Drug and Food Clinical Evaluation, Osaka City University Hospital
  • TOKAI Hidekichi
    Center for Drug and Food Clinical Evaluation, Osaka City University Hospital
  • FUJIMOTO Sachie
    Center for Drug and Food Clinical Evaluation, Osaka City University Hospital
  • FUJII Hisako
    Center for Drug and Food Clinical Evaluation, Osaka City University Hospital
  • HASHIMOTO Fumihiko
    Graduate School of Economics, Osaka City University
  • TAKEUCHI Kazuhide
    Internal Medicine and Cardiology, Osaka City University Medical School
  • HIRAYAMA Yoshinobu
    Center for Drug and Food Clinical Evaluation, Osaka City University Hospital

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Other Title
  • キシロオリゴ糖配合食酢飲料の健常人に対する過剰摂取時の安全性試験
  • キシロオリゴトウ ハイゴウ ショクズ インリョウ ノ ケンジョウジン ニ タイスル カジョウ セッシュジ ノ アンゼンセイ シケン

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A placebo-controlled, double-blind study was performed to assess the safety of excessive intake of xylooligo-saccharide-containing vinegar drinks. Forty-six volunteers with fecal frequency of less than 5 times per week were enrolled and the effects of the drink on defecation were also examined. Two-week administration of the test drink (at three times the daily recommended intake) did not affect blood pressure, hematological data, blood chemistry or urinalysis. No abnormal changes or severe adverse events related to the test drink were observed. The test drink significantly increased the fecal frequency of mildly constipated subjects but the placebo had no effect. These data indicate that the xylooligosaccharide-containing vinegar drink is safe in healthy subjects and that the drink has beneficial effects on defecation in mildly constipated subjects.

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