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

RecruitingNAAges 18 Years - 45 YearsFemaleGeorge Washington University
NCT06548828 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • NNS Restriction Intervention
  • Control Intervention
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Where

1 site
The George Washington University
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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