NCT06548828 Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
| NCT ID | NCT06548828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Washington University |
| Condition | Gestational Diabetes Mellitus in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2024-08-19 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06548828 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Gestational Diabetes Mellitus in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06548828 currently recruiting?
Yes, NCT06548828 is actively recruiting participants. Contact the research team at asylvets@gwu.edu for enrollment information.
Where is the NCT06548828 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06548828 clinical trial?
NCT06548828 is sponsored by George Washington University. The trial plans to enroll 324 participants.
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