Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
George Washington University
324 participants
Aug 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Pregnant
- ≤ 16 weeks gestation
- Singleton pregnancy
- Report frequent NNS beverage consumption (≥ 7 servings/week)
- 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 Criteria7
- 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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Interventions
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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06548828