Recruiting

NNS Restriction

Sponsor:

George Washington University

Code:

NCT06548828

Conditions

Gestational Diabetes Mellitus in Pregnancy

Glucose Intolerance During Pregnancy

Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

NNS Restriction Intervention

Control Intervention

Study Details

Brief summary:

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Glucose Intolerance During Pregnancy

Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Study ID

NCT06548828

Start date

Aug 19, 2024

Status verified date

Feb, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 (\>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.

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control (Group 1)

Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention.

active comparator: NNS Restriction in Lactation (Group 2)

Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.

active comparator: NNS Restriction in Pregnancy and Lactation (Group 3)

Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.

Interventions

NNS Restriction Intervention

Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health.

Provide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS.

Emphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead.

Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages.

Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS

Control Intervention

Counsel about best practices for home safety and babyproofing.

Provide a detailed booklet to take home, which will provide information about home safety and baby proofing.

Educate about common causes of accidental infant and young child injuries or death.

Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.

Primary outcome measure

  • Infants' adiposity [ Time Frame: At 6 months of age ]
  • Mothers' incremental area under glucose response curves [ Time Frame: At 28 weeks gestation ]

Central Contacts and Locations

Central contacts

Allison C Sylvetsky, PhD

202-994-5602asylvets@gwu.edu

Locations

The George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Allison C Sylvetsky, PhD

202-994-5602asylvets@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Non-nutritive sweeteners (NNS)
  • Pregnancy
  • Lactation
  • Infant fat mass
  • Gestational diabetes (GDM)
  • Glucose tolerance
  • PeaPod

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by George Washington University on 2026-02-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.