About this trial

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.

Eligibility criteria

Qualifiers

Pregnant

≤ 16 weeks gestation

Singleton pregnancy

Report frequent NNS beverage consumption (≥ 7 servings/week)

Disqualifiers

Physical or mental concerns preventing study participation;

Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;

Tobacco or drug use during pregnancy;

Alcohol consumption (>1 drink per week) during pregnancy;

Trial design

Treatments tested in this trial

  • NNS Restriction Intervention
  • Control Intervention

Treatment groups

324 Participants
are divided into 3 treatment groups

Locations

1
The George Washington University20037, Washington D.C.District of Columbia, United States

Sponsors and collaborators

George Washington University

Lead sponsor

Children's Hospital Los Angeles

Collaborator

Children's National Research Institute

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator