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New treatment option for Gestational Diabetes Mellitus in Pregnancy
Official title Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
ClinicalTrials.gov ID: NCT06548828
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant
- ≤ 16 weeks gestation
- Singleton pregnancy
- Report frequent NNS beverage consumption (≥ 7 servings/week)
- 18-45 years of age
You likely can't join if
- 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)...
- Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.