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

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.