324 Participants Needed

Reducing Artificial Sweeteners for Diabetes in Pregnancy

Recruiting at 1 trial location
AC
Overseen ByAllison C Sylvetsky, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: George Washington University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

Why 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

Pregnant
Singleton pregnancy
Able to read English at a 5th grade level
See 4 more

Exclusion Criteria

Pre-existing diabetes or GDM in a previous pregnancy
Tobacco or drug use during pregnancy
Alcohol consumption (>1 drink per week) during pregnancy
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Pregnancy and lactation period

Follow-up

Participants are monitored for maternal and infant outcomes, including glucose tolerance, body composition, and gut microbiome.

6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • NNS Restriction Intervention
Trial Overview The study compares two groups: one that restricts NNS intake during pregnancy and lactation, and a control group with no restrictions. The impact on infant body composition, maternal glucose levels, and both the mother's and infant’s gut health are being observed.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Control (Group 1)Active Control1 Intervention
Group II: NNS Restriction in Lactation (Group 2)Active Control2 Interventions
Group III: NNS Restriction in Pregnancy and Lactation (Group 3)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

Children's Hospital Los Angeles

Collaborator

Trials
257
Recruited
5,075,000+

Children's National Research Institute

Collaborator

Trials
227
Recruited
258,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better control of glycated hemoglobin levels in diabetes clinic settings compared to usual care.
Women receiving care under the nutrition practice guidelines had a lower proportion of elevated glycated hemoglobin levels (8.1%) compared to those in the usual care group (13.6%), suggesting that these guidelines may improve management of gestational diabetes.
Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes.Reader, D., Splett, P., Gunderson, EP.[2022]
A systematic review of nine randomized controlled trials involving 979 participants with diabetes found inconclusive evidence regarding the effects of non-nutritive sweeteners (NNS) on important health outcomes like HbA1c levels and body weight, indicating very low certainty in the results.
The studies showed that NNS consumption did not significantly improve or worsen HbA1c levels or body weight compared to sugar, placebo, or other low-calorie sweeteners, and there was a lack of data on adverse events and other health-related impacts.
Non-nutritive sweeteners for diabetes mellitus.Lohner, S., Kuellenberg de Gaudry, D., Toews, I., et al.[2022]
Recent randomized clinical trials (RCTs) on nonnutritive sweeteners (NNSs) found that most types, particularly artificial ones like sucralose and aspartame, generally do not affect blood glucose or insulin levels, indicating limited efficacy for glycaemic control.
Some studies did show an acute insulin response to sucralose, suggesting that certain NNSs may have specific effects, but overall, more research is needed to clarify their impact on glycaemic control and to explore different types of NNSs.
Recent evidence for the effects of nonnutritive sweeteners on glycaemic control.Ahmad, SY., Azad, MB., Friel, J., et al.[2020]

Citations

Artificial sweeteners and their implications in diabetes: a reviewHowever, recent research has indicated that the use of NNS may disrupt the balance of gut microbiota and lead to impaired glucose tolerance in ...
Effect of perinatal consumption of low-calorie sweetener on ...Based on the evidence available, LCS consumption in pregnancy was associated with increased risk of preterm birth and gestational diabetes.
Non‐nutritive sweeteners for diabetes mellitus - Lohner, SMany people with type 1 or type 2 diabetes use NNS as a replacement for nutritive sweeteners to control their carbohydrate and energy intake.
Effects of a Non-nutritive Sweetener Reduction Intervention ...The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39299048/
A secondary data analysis of the CHiMINCs-II cohortThe consumption of NNS, particularly sucralose, is associated with an increased risk of GDM in pregnant women.
NCT06548828 | Effects of a Non-nutritive Sweetener ...Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' body composition by assessing percent body fat.
Effects of a Non-nutritive Sweetener Reduction Intervention ...The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially ...
Reducing Artificial Sweeteners for Diabetes in PregnancyThe NNS Restriction Intervention is unique because it focuses on reducing the intake of artificial sweeteners (like Splenda and Stevia) during pregnancy ...
Maternal consumption and perinatal exposure to non- ...Whether NNSs are useful in reducing gestational diabetes is little studied and results are contradictory. ... artificial sweeteners consumption on ...
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