Bito Hiroyuki, Hamaguchi Norihisa, Hirai Hirokazu, Ogawa Koichi
Nihon Shokuhin Kako Co., Ltd.
J Toxicol Sci. 2016 Feb;41(1):33-44. doi: 10.2131/jts.41.33.
Resistant glucan mixture (RGM), a water-soluble dietary fiber produced by the random polymerization of glucose with activated carbon as a catalyst at a high temperature, has been recently developed by our group. There has been little physiological and safety research into RGM and therefore we now present our research into its safety. A reverse mutation assay indicated that RGM is not mutagenic either with or without metabolic activation. We conducted a 90-day subchronic oral toxicity study in rats. Male and female rats fed either a 3% or 5% w/w RGM diet had no muddy or watery stools, and there was no RGM-related death in any group. Although some parameters in the 3% and 5% w/w groups were significantly different from those in the control group, these changes were not due to any toxicity from RGM. The results indicated that the No Observed Adverse Effect Level (NOAEL) of RGM was 3.3 and 3.9 g/kg body weight (BW) per day in male and female rats, respectively. We then studied the gastrointestinal effects of RGM in healthy adult humans. Gastrointestinal symptoms, such as gurgling sounds, flatus and tenesmus, were mild and transient. In men and women, the maximum no-effect dose for diarrhea was more than 0.9 g RGM /kg BW. The results of our current safety assessment studies suggest that RGM is safe for human consumption.
抗性葡聚糖混合物（RGM）是一种通过葡萄糖在高温下以活性炭为催化剂随机聚合产生的水溶性膳食纤维，最近由我们团队研发。目前针对RGM的生理和安全性研究较少，因此我们现在展示关于其安全性的研究。一项回复突变试验表明，无论有无代谢活化，RGM均无致突变性。我们在大鼠中进行了为期90天的亚慢性经口毒性研究。喂食3%或5%（w/w）RGM饮食的雄性和雌性大鼠均无稀便或水样便，且任何组均无与RGM相关的死亡。尽管3%和5%（w/w）组的一些参数与对照组有显著差异，但这些变化并非由RGM的任何毒性引起。结果表明，RGM在雄性和雌性大鼠中的未观察到有害作用水平（NOAEL）分别为每天3.3和3.9克/千克体重（BW）。然后我们研究了RGM对健康成年人的胃肠道影响。胃肠道症状，如咕噜声、肠胃气胀和里急后重，均较轻且为短暂性。在男性和女性中，腹泻的最大无作用剂量超过0.9克RGM/千克体重。我们目前安全性评估研究的结果表明，RGM对人类食用是安全的。
