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NCT06548828

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

Recruiting now NA Last updated 18 February 2026
What this trial tests

NA trial testing NNS Restriction Intervention in Gestational Diabetes Mellitus in Pregnancy in 324 participants. Currently enrolling.

Timeline
19 August 2024
Primary endpoint
29 February 2028
1 February 2029

Quick facts

Lead sponsorGeorge Washington University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment324
Start date19 August 2024
Primary completion29 February 2028
Estimated completion1 February 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

George Washington University

Who can join

Adults 18 to 45, female only, with Gestational Diabetes Mellitus in Pregnancy or Glucose Intolerance During Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Microbe on the move: <i>Akkermansia</i> in infectious diseases and emerging roles in gynecological health.
    Marroquin SM, Doran KS. · · 2026 · PMID 42060851 · DOI 10.1128/jb.00491-25

Verify or expand the search:

Other recruiting trials for Gestational Diabetes Mellitus in Pregnancy

Currently open trials in the same condition.

Other George Washington University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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