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プロバイオティクス Lactobacillus gasseri SBT2055 を含有する発酵乳の過剰摂取時の安全性
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JPY
Abstract
Objective A randomized double-blind placebo-controlled study for 4 weeks was conducted to evaluate the safety for excessive intake of the fermented milk containing the probiotic Lactobacillus gasseri(L. gasseri)SBT2055 in healthy adults. Methods Subjects(n=34;14 male, 20 female)were asked to ingest 3cups of fermented milk containing L. gasseri SBT2055 or placebo(100 g/cup)at one time per day for 4 weeks. Results Changes in the body weight, BMI, vital signs and urine parameters were not observed in the test group during intake period. Although statistically significant increase in 3-hydroxybutyric acid, total ketone bodies, uric acid and potassium were observed after 4 weeks of intake in test group and significant difference between two groups was observed in serum calcium after 4 weeks of intake, these were considered to be no clinically concerning changes. No adverse event was observed during intake period in both groups. Conclusions These results indicated the safety of the fermented milk containing L. gasseri SBT2055 in healthy adults when consumed excessively.
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