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

George Washington University · with Children's Hospital Los Angeles, Children's National Research Institute · NCT06548828

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
324
US sites recruiting
1
Study start
August 19, 2024
Record last updated
February 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: NNS Restriction Intervention; Control Intervention

Conditions: Gestational Diabetes Mellitus in Pregnancy; Glucose Intolerance During Pregnancy; Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 (\>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.

Recruiting US locations

  • The George Washington University

    Washington D.C., DC 20037

    Site contact: Allison C Sylvetsky, PhD · 202-994-5602 · asylvets@gwu.edu

Study contacts (from the official record)

  • Allison C Sylvetsky, PhD · 202-994-5602 · asylvets@gwu.edu
All diabetes studies in District of Columbia →
Effects of a Non-nutritive Sweetener Reduction Intervention in… (NCT06548828) | Bored Studies