Afriyie-Gyawu E, Wang Z, Ankrah N-A, Xu L, Johnson N M, Tang L, Guan H, Huebner H J, Jolly P E, Ellis W O, Taylor R, Brattin B, Ofori-Adjei D, Williams J H, Wang J-S, Phillips T D
Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Jul;25(7):872-84. doi: 10.1080/02652030701854758.
To assess the potential interference of NovaSil (NS) clay with micronutrients in humans, vitamins A and E and minerals (15 nutrient and 15 non-nutrient minerals) were measured in serum samples from a 3-month intervention trial with NS. Participants (n = 177) were randomly divided into three groups that received 3.0 g NS day(-1) (high dose, HD), 1.5 g NS day(-1) (low dose, LD), or placebo (PL). Levels of vitamins A and E in serum were comparable among the three study groups at baseline, 1 month and 3 months of NS intervention. Gender-stratified non-parametric mixed-effect model analysis showed no significant effects of dose and dose-time interaction for levels of vitamins A and E. A significant time effect was detected; however, it was limited to an increase in vitamin E in the male participants over the course of the study. No significant differences were found in levels of the nutrient and non-nutrient minerals between the HD and PL groups at baseline and 3 months of NS intervention, except for strontium levels. Strontium was significantly increased (p < 0.001) in the HD group (male = 113.65 +/- 28.00 microg l(-1); female = 116.40 +/- 24.26 microg l(-1)) compared with the PL group (male = 83.55 +/- 39.90 microg l(-1); female = 90.47 +/- 25.68 microg l(-1)) following the 3-month intervention with NS. These results, combined with safety and efficacy data, confirm that NS clay is highly effective in reducing aflatoxin exposure and acts as a selective enterosorbent that does not affect the serum concentrations of important vitamins and nutrient minerals in humans.
为评估诺瓦西尔（NS）粘土对人体微量营养素的潜在干扰，在一项为期3个月的NS干预试验的血清样本中检测了维生素A、维生素E和矿物质（15种营养矿物质和15种非营养矿物质）。参与者（n = 177）被随机分为三组，分别接受3.0 g NS/天（高剂量，HD）、1.5 g NS/天（低剂量，LD）或安慰剂（PL）。在NS干预的基线、1个月和3个月时，三个研究组血清中维生素A和维生素E的水平相当。性别分层的非参数混合效应模型分析显示，维生素A和维生素E水平的剂量及剂量-时间交互作用无显著影响。检测到显著的时间效应；然而，这仅限于男性参与者在研究过程中维生素E的增加。在NS干预的基线和3个月时，HD组和PL组之间的营养矿物质和非营养矿物质水平除锶水平外无显著差异。与PL组（男性 = 83.55 ± 39.90 μg l⁻¹；女性 = 90.47 ± 25.68 μg l⁻¹）相比，HD组（男性 = 113.65 ± 28.00 μg l⁻¹；女性 = 116.40 ± 24.26 μg l⁻¹）在接受3个月NS干预后锶水平显著升高（p < 0.001）。这些结果与安全性和有效性数据相结合，证实NS粘土在降低黄曲霉毒素暴露方面非常有效，并且作为一种选择性肠吸附剂，不会影响人体重要维生素和营养矿物质的血清浓度。
