Intergenerational transmission of sucralose and acesulfame-potassium from mothers to their infants via human milk: a pharmacokinetic study

Abstract

Background

Low-calorie sweetener (LCS) consumption is prevalent among lactating mothers, yet infants’ exposure to LCS in human milk is not well-characterized.

Objectives

Conduct a pharmacokinetic study of sucralose and acesulfame-potassium (ace-K) in mothers’ milk and plasma over 72 h and in infants’ plasma.

Methods

Following baseline blood and milk collection, mothers (n = 40) consumed 20 oz 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 h after beverage ingestion, and milk was expressed at 1, 2, 3, 4, 6, 8, 12, and 24 h postingestion. 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 the mother’s plasma and milk were analyzed using noncompartmental methods.

Results

Ace-K rapidly entered human milk with the largest observed concentration of 373.0 (coefficient of variation 69%) ng/mL first detected 4 h following diet beverage ingestion. Sucralose appeared in human milk 1–2 h after diet beverage ingestion with the largest observed concentration of 7.2 (coefficient of variation 63%) ng/mL first detected 7 h postingestion. The mean 24-h milk to plasma ratio of ace-K was 1.75 [standard deviation (SD) 1.37] with a mean relative infant dose of 1.59% (SD 1.72%). Ace-K was detected in all infants’ plasma with an mean concentration of 9.2 (SD% 14.8) ng/mL ∼6 h after maternal beverage ingestion. The mean 24-h milk to plasma ratio of sucralose was 0.15 (SD 0.06) with a mean relative infant dose of 0.04% (SD 0.02%). Sucralose was detected in only 15 infants’ plasma, and the mean concentration was 5.0 (SD% 7.1) ng/mL ∼5 h 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 the effects of early-life sucralose and ace-K exposure via human milk on infants’ health.

This trial was registered at clinicaltrials.gov as NCT05379270.