Reducing non-nutritive sweeteners during pregnancy and lactation
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
NA · George Washington University · NCT06548828
This study is testing if cutting back on non-nutritive sweeteners during pregnancy and breastfeeding can improve health for both mothers and their babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | George Washington University (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06548828 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of reducing non-nutritive sweeteners (NNS) on maternal and infant health outcomes during pregnancy and lactation. Pregnant women who frequently consume NNS will be randomly assigned to either an NNS-restriction intervention or a control group with no restrictions. The study aims to assess how NNS consumption affects infant body composition, maternal blood sugar levels, and the infants' gut microbiome and metabolome. The findings could inform guidelines on NNS consumption for improving metabolic health in mothers and infants.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45, less than 16 weeks gestation, who frequently consume NNS and intend to breastfeed.
Not a fit: Patients with pre-existing gastrointestinal disorders, significant substance use, or those on medications affecting metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health recommendations for pregnant women, potentially reducing the risk of obesity and metabolic diseases in infants.
How similar studies have performed: While the effects of NNS on pregnancy outcomes are not well understood, this approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia
- The George Washington University — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Allison C Sylvetsky, PhD
- Email: asylvets@gwu.edu
- Phone: 202-994-5602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation, Non-nutritive sweeteners, Pregnancy, Lactation, Infant fat mass, Gestational diabetes