Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes

The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.

NCT Number	NCT06548828
Lead Sponsor	George Washington University Collaborators: Children's Hospital Los Angeles, Children's National Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
Enrollment	324 participants
Start Date	2024-08-19
Primary Completion	2028-02-29 (estimated)
Study Completion	2029-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-18