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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT06548828
Status
Recruiting
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Conditions

  • Gestational Diabetes Mellitus in Pregnancy
  • Glucose Intolerance During Pregnancy
  • Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • NNS Restriction Intervention — BEHAVIORAL
    Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health. Provide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS. Emphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead. Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages. Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS
  • Control Intervention — BEHAVIORAL
    Counsel about best practices for home safety and babyproofing. Provide a detailed booklet to take home, which will provide information about home safety and baby proofing. Educate about common causes of accidental infant and young child injuries or death. Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.

Study Details

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.

Key Dates

Start date
Aug 19, 2024
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Infants' adiposity [ Time Frame: At 6 months of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The George Washington UniversityWashington D.C.District of Columbia20037
Allison C Sylvetsky, PhD
[email protected]
202-994-5602

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