Actively Recruiting
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Led by George Washington University · Updated on 2026-02-18
324
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
G
George Washington University
Lead Sponsor
C
Children's Hospital Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women who are less than or equal to 16 weeks gestation
- Singleton pregnancy
- Frequent consumption of non-nutritive sweetener beverages (7 or more servings per week)
- Aged between 18 and 45 years
- Able to read English at a 5th grade level
- Intend to breastfeed for at least the first 6 months of the infant's life
- Infant participation requires the mother to be enrolled and provide assent
You will not qualify if you...
- Physical or mental health concerns preventing participation
- Use of medications affecting weight, body composition, insulin resistance, or lipid profiles (e.g., metformin, GLP-1 agonists)
- Tobacco or drug use during pregnancy
- Alcohol consumption of more than 1 drink per week during pregnancy
- Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (such as Crohn's disease, ulcerative colitis, or inflammatory bowel disease) that may affect NNS absorption or gut microbiota
- Known or suspected genetic fetal abnormalities or congenital birth defects
- History of gastric bypass surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
A
Allison C Sylvetsky, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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