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

RecruitingHealthy volunteers welcome

Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)

Who can join

Ages 18 to 45 · Women · Healthy volunteers welcome

Full eligibility criteria

Inclusion Criteria:

* Pregnant
* ≤ 16 weeks gestation
* Singleton pregnancy
* Report frequent NNS beverage consumption (≥ 7 servings/week)
* 18-45 years of age
* Able to read English at a 5th grade level; and
* Intend to breastfeed for at least the first 6 months of life.
* For infants: The mother must be enrolled and provide assent for the infant to participate.

Exclusion Criteria:

* 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 (\&gt;1 drink per week) during pregnancy;
* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;
* Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.
* History of prior gastric bypass surgery.

About the study

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.

What is being tested

NNS Restriction Intervention (behavioral)
Control Intervention (behavioral)

Sponsor: George Washington University · Participants: 324 · Started: Aug 19, 2024

Contact the study team

Allison C Sylvetsky, PhD · Phone: 202-994-5602

Official record on ClinicalTrials.gov — NCT06548828

Locations in the U.S.

District of Columbia

The George Washington University, Washington D.C.

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.