背景:低热量甜味剂(LCS)的消费在哺乳期妇女中普遍存在,然而,婴儿接触母乳中的LCS的特征并不明确。
目的:进行三氯蔗糖和ACE-K在母亲乳汁和血浆中72小时的药代动力学研究,和婴儿血浆。
方法:在基线血液和牛奶收集之后,母亲(n=40)食用20盎司的蔓越莓汁,含有三氯半乳蔗糖和ace-K。在摄入饮料后0.5、1、1.5、2、3、4、6、8、12、24、48和72小时从母亲收集血样。在摄入后1、2、3、4、6、8、12和24小时表达乳汁。每个婴儿都采集了一份血样,其时机使用基于药代动力学模型的模拟确定.使用非隔室方法分析了来自母亲血浆和乳汁的LCS的浓度-时间曲线。
结果:Ace-K迅速进入人乳,在饮食饮料摄入后4小时首次检测到最大观察浓度为373.0(CV69%)ng/ml。三氯蔗糖在饮食饮料摄入后1-2小时出现在人乳中,在摄入后7小时首次检测到最大观察浓度为7.2(CV63%)ng/ml。ace-K的平均24小时牛奶血浆比(MPR)为1.75(SD1.37),平均相对婴儿剂量(RID)为1.59%(SD1.72%)。在母亲摄入饮料后约6小时,在所有婴儿血浆中检测到ace-K,平均浓度为9.2(SD%14.8)ng/ml。三氯蔗糖的平均24小时MPR为0.15(SD0.06),平均RID为0.04%(SD0.02%)。仅在15名婴儿血浆中检测到三氯蔗糖,平均浓度为5.0(SD%7.1)ng/ml,饮食饮料摄入后约5小时。
结论:Ace-K从人乳迅速转移到婴儿循环中,而三氯半乳蔗糖的浓度低得多,在一些但不是所有婴儿中检测到。未来的研究应该调查生命早期三氯半乳蔗糖和ACE-K通过母乳暴露对婴儿健康的影响。
背景:NCT05379270,https://classic。
结果:gov/ct2/show/NCT05379270。
BACKGROUND: Low-calorie sweetener (LCS) consumption is prevalent among lactating women, yet infants\' exposure to LCS in human milk is not well-characterized.
OBJECTIVE: Conduct a pharmacokinetic study of sucralose and ace-K in mothers\' milk and plasma over 72 hours, and in infants\' plasma.
METHODS: Following baseline blood and milk collection, mothers (n=40) consumed 20-ounces of diet cranberry juice, containing sucralose and ace-K. Blood samples were collected from the mother 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after beverage ingestion, and milk was expressed at 1, 2, 3, 4, 6, 8, 12, and 24 hours post-ingestion. One blood sample was collected from each infant, the timing of which was determined using pharmacokinetics model-based simulation. Concentration-time profiles of LCS from mother\'s plasma and milk were analyzed using non-compartmental methods.
RESULTS: Ace-K rapidly entered human milk with the largest observed concentration of 373.0 (CV 69%) ng/ml first detected 4 hours following diet beverage ingestion. Sucralose appeared in human milk 1-2 hours after diet beverage ingestion with the largest observed concentration of 7.2 (CV 63%) ng/ml first detected 7 hours post-ingestion. The mean 24-hour milk to plasma ratio (MPR) of ace-K was 1.75 (SD 1.37) with a mean relative infant dose (RID) of 1.59% (SD 1.72%). ace-K was detected in all infants\' plasma with an average concentration of 9.2 (SD% 14.8) ng/ml approximately 6 hours after maternal beverage ingestion. The mean 24-hour MPR of sucralose was 0.15 (SD 0.06) with a mean RID of 0.04% (SD 0.02%). Sucralose was detected in only fifteen infants\' plasma, and the average concentration was 5.0 (SD% 7.1) ng/ml, approximately 5 hours after diet beverage ingestion.
CONCLUSIONS: Ace-K rapidly transfers from human milk into infants\' circulation whereas sucralose was detected at much lower concentrations and in some but not all infants. Future research should investigate effects of early life sucralose and ace-K exposure via human milk on infants\' health.
BACKGROUND: NCT05379270, https://classic.
RESULTS: gov/ct2/show/NCT05379270.