The MILK study: Investigating intergenerational transmission of low-calorie sweeteners in breast milk

• Published in: Contemporary clinical trials communications Vol. 36; p. 101212
• Main Authors: Langevin, Brooke, Gopalakrishnan, Mathangi, Kuttamperoor, Janae, Van Den Anker, John, Murphy, Jeanne, Arcaro, Kathleen F., Daines, Dina, Sylvetsky, Allison C.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.12.2023; Elsevier
• Subjects: Acesulfame-potassium; Intergenerational transmission; Low calorie sweeteners; Pharmacometrics; Sucralose; Pharmacometrics; Low calorie sweeteners; Sucralose; Intergenerational transmission; Acesulfame-potassium
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2023.101212

Forty-four percent of lactating women in the United States consume beverages containing low calorie sweeteners (LCS), and the presence of LCS in the food supply has continued to increase in recent years. While LCS are approved by the United States Food and Drug Administration (FDA) and are believed to be safe for human consumption, intergenerational LCS transmission and the health impacts of early life LCS exposure are severely understudied. In a tightly controlled, single site, prospective interventional study, mothers' plasma and breast milk, and infants’ plasma will be collected from 40 mother-infant dyads over the course of 72 h, with rich sampling following maternal ingestion of a LCS sweetened beverage containing sucralose and acesulfame potassium (ace-K). Concentration-time data will be used to build maternal and infant pharmacokinetic models for future simulations and analysis. This study aims to measure LCS concentrations in breast milk, maternal plasma, and infant plasma, to gain insight into infant exposure and inform recommendations for LCS consumption during breastfeeding. •A key strength of the study is the rich sampling and measurement of sucralose and ace-K in maternal breast milk and plasma under tightly controlled experimental conditions.•This study will be the first to directly measure infants' LCS exposure following maternal ingestion of a LCS-containing beverage.•This study will specifically measure sucralose and ace-K concentrations acknowledging the marked heterogeneity across different types of LCS.•This study will contribute to the first pharmacokinetic model of sucralose and ace-K in infants and will enhance the present understanding of intergenerational LCS transmission.•Due to the enrollment of exclusively breastfeeding mothers, it is difficult to estimate the volume of the milk consumed by the infant. This limits our ability to accurately determine the dose of sucralose and ace-K the infant ingested when modeling.•Mothers will self-report their daily dietary intake; therefore, some records may be incomplete or inaccurate.