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Study on Non-nutritive Sweeteners in Pregnancy and Lactation

This study is looking at how consuming non-nutritive sweeteners (NNS) during pregnancy and breastfeeding might affect a baby's body fat and a mother's blood sugar. If you are pregnant, 18-45 years old, less than 16 weeks pregnant with one baby, and drink NNS beverages frequently (7 or more servings per week), you might be able to join. You should also be able to read English and plan to breastfeed for at least six months. Participants will either reduce their NNS intake or receive counseling on home safety. Researchers will measure your baby's body fat at 6 months of age and your blood sugar at 28 weeks of pregnancy to see if the intervention is successful. The current status of this study is unclear.

Study design
This interventional study plans to enroll 324 pregnant women who frequently consume non-nutritive sweeteners and will randomly assign them to either an NNS restriction group or a control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Infants' body fat will be measured at 6 months of age, and mothers' blood sugar will be measured at 28 weeks gestation.

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NCT06548828

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

Recruiting
NAAges 18–45InterventionalTreatment
George Washington University
~324 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:NNS Restriction InterventionControl Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Infants' adiposity
Measured over At 6 months of age
+1 more outcome measured

Conditions

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

Explore related trials

Gestational DiabetesGlucose IntolerancePregnancy

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Allison C Sylvetsky, PhD
[email protected]
202-994-5602
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Infants' adiposityAt 6 months of age

    Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation influences infants' adiposity, which is known to be predictive of potential future obesity risk by assess infants' fat mass percent.

  • Mothers' incremental area under glucose response curvesAt 28 weeks gestation

    Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.