Reducing non-nutritive sweeteners during pregnancy and lactation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.