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NCT06548828 · ClinicalTrials.gov registry record · NA
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
A NA study of Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy, sponsored by George Washington University.
- Recruiting
- Registry status
- NA
- Development phase
- 324
- Enrollment target
- 1
- Study location
NCT06548828: Recruiting NA study of Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy, sponsored by George Washington University.
NCT06548828 is a NA study of Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy that is actively recruiting participants, run by George Washington University. The registered enrollment target is 324 participants, below the 1,840-participant average among 9 other Gestational Diabetes Mellitus in Pregnancy trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548828, a NA study of Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- NA
- Development phase
- 324 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL NNS Restriction Intervention
- BEHAVIORAL Control Intervention
Study Locations (1)
District of Columbia
- The George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2029-02-01 |
| Phase | NA |
What NCT06548828 shows while recruiting
NCT06548828 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 1,840-participant average among 9 other Gestational Diabetes Mellitus in Pregnancy trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Gestational Diabetes Mellitus in Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which NNS Restriction Intervention is the first listed.
NCT06548828 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06548828 about?
NCT06548828 is a clinical study titled "Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes". 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 ...
What is the current status of trial NCT06548828?
This trial is currently recruiting. It is a NA study. The enrollment target is 324 participants. The study started on 2024-08-19. Estimated completion is 2029-02-01.
What conditions does trial NCT06548828 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation.
What interventions are being tested in trial NCT06548828?
The interventions under investigation include: NNS Restriction Intervention (BEHAVIORAL), Control Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06548828?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06548828 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06548828's enrollment target sits among peer trials
324 3rd of 9 higher than 7 of 9 other Gestational Diabetes Mellitus in Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gestational Diabetes Mellitus in Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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