Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
United States
Washington, D.c.
The George Washington University
RECRUITING
Washington D.c.
Contact Information
Primary
Allison C Sylvetsky, PhD
asylvets@gwu.edu
202-994-5602
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2029-02
Participants
Target number of participants: 324
Treatments
Active_comparator: Control (Group 1)
Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention.
Active_comparator: NNS Restriction in Lactation (Group 2)
Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
Active_comparator: NNS Restriction in Pregnancy and Lactation (Group 3)
Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.
Sponsors
Collaborators: Children's National Research Institute, Children's Hospital Los Angeles, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: George Washington University

This content was sourced from clinicaltrials.gov