Examination for laxative effect and safety of sugar alcohol-containing chewing gum in healthy subjects

T. Oku, Mariko Nakamura, Michiru Ishiguro, Kenichi Tanabe, Y. Yamaguchi, Sadako Nakamura
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Abstract

Three-fold amounts of ordinary intake (2 pieces by 4-times) of sugar alcohol-containing chewing gum were ingested by 15 male and 15 female subjects 4-times in a day (total 24 pieces) for 1week, and the effects on blood biochemical parameters, urinary property, fecal conditions including fecal frequency and constituents and abdominal symptoms were observed. The study design was randomized single blinded placebo controlled crossover experiment. A total of 24 pieces of test chewing gum contained total sugar alcohols 21.9g (maltitol 14.4g, xylitol 7.2g and others 0.3g) and placebo gum was replaced with sucrose instead of sugar alcohols. No high osmotic diarrhea was caused in every subject. Fecal conditions including fecal frequency and constituents were not significantly different between test and placebo chewing gum groups. Abdominal symptoms were also not significantly different between test and placebo chewing gum groups, but flatus frequently occurred in test chewing gum group. Biochemical data and components of blood and urinary properties were not affected by ingestion of test chewing gum. These results are demonstrated that even 3-fold amounts of ingestion (24 pieces) of ordinary intake of sugar alcohol-containing chewing gum in a day does not induce harmful effects in healthy subjects and the ordinary intake of sugar alcohol-containing chewing gum is safe.
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含糖醇口香糖在健康人体内的通便效果及安全性检验
15名男性和15名女性受试者每天4次(共24片)摄入含糖酒精口香糖,每日摄入正常摄入量的3倍(2片乘4片),持续1周,观察其对血液生化指标、尿性、大便频率和成分等粪便状况及腹部症状的影响。研究设计为随机单盲安慰剂对照交叉实验。共有24块测试口香糖含有总糖醇21.9g(麦芽糖醇14.4g,木糖醇7.2g,其他0.3g),安慰剂口香糖用蔗糖代替糖醇。所有受试者均未出现高渗透性腹泻。在测试组和安慰剂组之间,粪便状况包括粪便频率和成分没有显著差异。试验组和安慰剂组腹部症状也无显著差异,但试验组经常出现肠胃胀气。生化数据和血液和尿液成分的性质没有受到摄入测试口香糖的影响。这些结果表明,即使是每天摄入普通含糖酒精口香糖的3倍量(24片)也不会对健康受试者产生有害影响,普通摄入含糖酒精口香糖是安全的。
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