90-day oral (gavage) study in rats with galactooligosaccharides syrup
90-day oral (gavage) study in rats with galactooligosaccharides syrup
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DOI：
10.1016/j.fct.2005.10.012
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发表时间：
2006-06-01
影响因子：
4.3
通讯作者：
Heimbach, James T.
中科院分区：
文献类型：
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作者：
Anthony, Joshua C.;Merriman, Todd N.;Heimbach, James T.
本研究对雄性和雌性Sprague Dawley大鼠进行了为期90天的口服（灌胃）研究，以研究2500或5000 mg/kg bw/天Vivinal (R)半乳糖低聚糖（GOS）糖浆的安全性。使用含有低聚果糖（FOS）的对照来匹配测试材料中的低聚糖和可消化糖（分别约为45%和30%），并评估它们是否对食物消费产生影响。测量包括临床观察、体重、食物消耗、血液学、凝血参数、血液化学、尿液分析、眼科检查、大体尸检、器官重量和组织学检查。饲喂两种浓度的GOS糖浆对除食用量外的其他参数均无影响。与反渗透去离子（RODI）水对照组相比，在两性中，以5000 mg/kg体重/天饲喂GOS糖浆处理的动物和用FOS对照组处理的动物的食物消耗量显著减少（7-13%）。基于本研究未见毒理学效应，在连续90天灌胃的情况下，Vivinal (R) GOS糖浆的NOAEL为5000 mg/kg bw/day。(c) 2005 Elsevier Ltd版权所有。
A 90-day oral (gavage) study was conducted in male and female Sprague Dawley rats to investigate the safety of Vivinal (R) galactooligosaccharides (GOS) syrup at 2500 or 5000 mg/kg bw/day. A reference control containing fructooligosaccharides (FOS) was used to match the oligosaccharide and digestible sugars in the test material (approximately 45% and 30%, respectively) and to assess if these had an impact on food consumption. Measurements included clinical observations, body weights, food consumption, hematology, clotting parameters, blood chemistries, urinalysis, ophthalmologic examinations, gross necropsies, organ weights, and histological examinations. There were no effects of feeding GOS syrup at either concentration on any parameter except food consumption. Statistically significant decreases (7-13%) in food consumption were seen in both sexes in the GOS syrup-treated animals at 5000 mg/kg bw/day and animals treated with the FOS control when compared to the reverse osmosis deionized (RODI) water controls. Based on the lack of toxicological effects in the study, the NOAEL for Vivinal (R) GOS syrup is 5000 mg/kg bw/day when administered by gavage for 90 consecutive days. (c) 2005 Elsevier Ltd. All rights reserved.