Reducing Artificial Sweeteners for Diabetes in Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how consuming artificial sweeteners during pregnancy and breastfeeding might affect a baby's weight and health. It seeks to determine if reducing these sweeteners can improve a baby's body composition and the mother's blood sugar levels. Participants will be divided into groups: some will maintain their usual intake, while others will reduce or eliminate it during pregnancy, lactation, or both. This approach is known as the NNS Restriction Intervention (Non-nutritive Sweetener Restriction). Pregnant women who consume at least seven servings of artificially sweetened beverages a week and plan to breastfeed might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance health guidelines for mothers and babies.
Will I have to stop taking my current medications?
The trial excludes participants who are taking medications that affect body weight, body composition, insulin resistance, or lipid profiles, so you may need to stop such medications to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the effects of non-nutritive sweeteners (NNS), such as Splenda and Stevia, on pregnancy are not fully understood. Some studies suggest a link between these sweeteners and risks like early birth and gestational diabetes, though not all research agrees.
There is limited evidence on the safety or side effects of reducing NNS. No major reports have specifically linked problems to reducing NNS intake during pregnancy or breastfeeding. Since the trial does not involve a new drug or medical procedure, safety concerns remain generally low. Participants will simply be asked to limit their use of certain sweeteners.
Overall, limiting NNS is expected to be manageable, as it involves dietary adjustments rather than medication or medical procedures.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring a fresh approach to managing diabetes during pregnancy by focusing on reducing artificial sweeteners, known as non-nutritive sweeteners (NNS). Unlike traditional methods that focus on insulin regulation and dietary adjustments, this trial looks at the potential impact of NNS restriction on pregnancy and lactation. The trial has three different approaches: one group continues their usual NNS consumption, another restricts NNS during lactation, and the third restricts NNS during both pregnancy and lactation. This investigation could provide new insights into how NNS affects maternal and infant health, potentially leading to more comprehensive dietary guidelines for pregnant individuals with diabetes.
What evidence suggests that this trial's NNS restriction interventions could be effective for reducing infant obesity and cardiometabolic disease risk?
Past studies have linked artificial sweeteners during pregnancy to certain health risks. Research shows these sweeteners can disrupt gut bacteria balance, potentially affecting blood sugar levels. Some studies have found a connection between artificial sweeteners and a higher risk of gestational diabetes, a type of diabetes that occurs during pregnancy. Evidence also suggests that using these sweeteners while pregnant could increase the chances of preterm birth. This trial will evaluate the effects of reducing artificial sweeteners, with one group continuing their usual consumption, another group restricting intake during lactation, and a third group restricting intake during both pregnancy and lactation. Limiting these sweeteners might help lower these risks for both mothers and their babies.46789
Are You a Good Fit for This Trial?
This trial is for pregnant women who often use non-nutritive sweeteners (NNS). They will be studied to see if avoiding NNS during pregnancy and breastfeeding affects their baby's risk of obesity and other health issues, as well as the mother's blood sugar levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are randomly assigned to an NNS-restriction intervention or a control group to assess the effects of NNS consumption during pregnancy and/or lactation.
Follow-up
Participants are monitored for maternal and infant outcomes, including glucose tolerance, body composition, and gut microbiome.
What Are the Treatments Tested in This Trial?
Interventions
- NNS Restriction Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor
Children's Hospital Los Angeles
Collaborator
Children's National Research Institute
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator