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

Launched by GEORGE WASHINGTON UNIVERSITY · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how cutting back on non-nutritive sweeteners (NNS), which are artificial sweeteners that add sweetness without calories, during pregnancy and breastfeeding might affect the health of both mothers and their babies. Researchers want to find out if limiting these sweeteners can help with mothers' blood sugar levels, baby body composition (like weight and fat), and the gut health of infants. The ultimate goal is to improve health recommendations regarding NNS use during pregnancy and breastfeeding to help reduce the risk of obesity and other health issues in children.

To be part of this study, women need to be pregnant with one baby and less than 16 weeks along. They should be between 18 and 45 years old and have been drinking NNS beverages frequently, at least seven times a week. Participants should also plan to breastfeed for at least the first six months. If someone joins the study, they will be placed in either a group that restricts NNS or a group that doesn’t change their NNS intake. The study is currently recruiting participants, and it’s important to note that certain health conditions might prevent someone from joining. Overall, this trial aims to gather valuable information that could help improve the health of mothers and their children.

Gender

FEMALE

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 agomists) 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.