薬理と治療

Abstract

Background　While acetic acid bacteria has not been associated with toxicities in short-term animal studies, our previous study evaluating the short-term consumption of large quantities of acetic acid bacteria themselves as a supplement was the first to evaluate such supplemental use in humans. Here, we conducted a study to confirm the safety of consuming moderate amounts of dry acetic acid bacterium powder when taken over 12 weeks. Methods　We tested soft capsules that contained an extract of an acetic acid bacteria（Gluconacetobacter hansenii GK-1）. Each capsule contained 45 mg of dry acetic acid bacterium powder, and each subject took 90 mg acetic acid bacteria per day. The subjects were men and women aged between 20 and 69 years who drank alcohol twice or more per week. The subjects took the predefined amount of acetic acid bacteria with a beverage before and during drinking alcohol during the 12-week study period. Subjects completed physical examinations, complete blood counts, blood biochemistry, and urinalysis, in addition to completing a diary of intake and subjective symptoms every day during the study. Results　Consumption of small quantities（90 mg╱day）of dry acetic acid bacterium powder food supplement was not associated with any significant adverse effects on weight, blood pressure, hematology, or clinical chemistry related to liver and kidney function over 12 weeks of intake. Although there were significant differences seen in some of the items, these were all changes within the range of the reference values. Conclusions　We observed no harms related to the daily consumption of a food supplement containing 90 mg of dry acetic acid bacterium powder over 12 weeks.