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

Last updated: December 11, 2024
Sponsor: George Washington University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Diabetes (Pediatric)

Treatment

Control Intervention

NNS Restriction Intervention

Clinical Study ID

NCT06548828
SweetPea
R01HD107427
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 toparticipate.

Exclusion

Exclusion Criteria:

  • Physical or mental concerns preventing study participation;

  • Medication (e.g., metformin; GLP-1 agomists) use that may affect body weight, bodycomposition, 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 impactNNS absorption or gut microbiota;

  • Known suspected/confirmed genetic fetal abnormalities or suspected or knowncongenital birth defects.

Study Design

Total Participants: 324
Treatment Group(s): 2
Primary Treatment: Control Intervention
Phase:
Study Start date:
August 19, 2024
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • The George Washington University

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

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