Status:
RECRUITING
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Children's Hospital Los Angeles
Children's National Research Institute
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Glucose Intolerance During Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06548828
Start Date
August 19 2024
End Date
February 1 2029
Last Update
October 7 2025
Active Locations (1)
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1
The George Washington University
Washington D.C., District of Columbia, United States, 20037