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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06548828
The ClinicalTrials.gov registry entry for NCT06548828 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,840-participant average among 9 other Gestational Diabetes Mellitus in Pregnancy trials with a reported enrollment target (82% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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