NCT06548828 · George Washington University
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
What this 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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
BEHAVIORAL
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 measures
Infants' adiposity
Time frame: At 6 months of age
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation influences infants' adiposity, which is known to be predictive of potential future obesity risk by assess infants' fat mass percent.
Mothers' incremental area under glucose response curves
Time frame: At 28 weeks gestation
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≤ 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.
Where
- Washington D.C., District of Columbia
Collaborators
Children's Hospital Los Angeles, Children's National Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations