Safety Assessment of Excessive Intake of Yogurt Containing Bifidobacterium lactis Bb-12 in Normal Volunteers

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  • MIURA Katsuyuki
    Departments of Applied Pharmacology and Therapeutics, Osaka City University Medical School
  • NAKAO Takafumi
    Departments of Applied 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
    Departments of Applied 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
  • BB-12を用いて調製したプレーンヨーグルトの健常人に対する過剰摂取時の安全性試験
  • BB 12 オ モチイテ チョウセイシタ プレーン ヨーグルト 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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Abstract

A placebo-controlled, double-blind study was performed to assess the safety of excessive intake of yogurt containing more than 107 cfu/g of Bifidobacterium lactis Bb-12. Fifty-seven volunteers with fecal frequency of less than five times per week were enrolled. The effect of the food on defecation was also examined. Two-week administration of the test food (more than 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 food were observed. The test food significantly increased the fecal frequency of mildly constipated subjects but placebo yogurt had a similar effect. Placebo yogurt tended to reduce stool hardness while the test food increased the frequency of stool with normal hardness maintained. These data indicate that yogurt containing Bifidobacterium lactis Bb-12 is safe in healthy subjects and that it has beneficial effects on defecation in mildly constipated subjects.

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