Last reviewed · How we verify
NCT06548828
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
NA trial testing NNS Restriction Intervention in Gestational Diabetes Mellitus in Pregnancy in 324 participants. Currently enrolling.
29 February 2028
Quick facts
| Lead sponsor | George Washington University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 324 |
| Start date | 19 August 2024 |
| Primary completion | 29 February 2028 |
| Estimated completion | 1 February 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NNS Restriction Intervention
- Control Intervention — full drug profile →
Conditions studied
- Gestational Diabetes Mellitus in Pregnancy — all drugs for Gestational Diabetes Mellitus in Pregnancy →
- Glucose Intolerance During Pregnancy — all drugs for Glucose Intolerance During Pregnancy →
- Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation — all drugs for Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation →
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):
-
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:
- PubMed search for NCT06548828
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gestational Diabetes Mellitus in Pregnancy
Currently open trials in the same condition.
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- NCT06874907 — First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring. · recruiting
- NCT06802861 — Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclam · recruiting
- NCT06005987 — Mobile App Logging for Diabetes in Pregnancy · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06548828 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by George Washington University
- Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06548828.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing