Gestational Diabetes Mellitus in PregnancyNCT06548828
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
A study testing NNS Restriction Intervention in people with Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy, run by George Washington University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
- What is being tested?
- NNS Restriction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The George Washington University
Washington D.C., District of Columbia, 20037
Allison C Sylvetsky, PhD, 202-994-5602, asylvets@gwu.edu
About this study
Official title: Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
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
- Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
- Being tested
- NNS Restriction Intervention, Control Intervention
- Keywords
- Non-nutritive sweeteners (NNS), Pregnancy, Lactation, Infant fat mass, Gestational diabetes (GDM), Glucose tolerance, PeaPod
- Medical subject headings
- Breast Feeding, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNS Restriction InterventionBehavioural
Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health.
Provide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS.
Emphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead.
Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages.
Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS
Control InterventionBehavioural
Counsel about best practices for home safety and babyproofing.
Provide a detailed booklet to take home, which will provide information about home safety and baby proofing.
Educate about common causes of accidental infant and young child injuries or death.
Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.
| Study group | Role | What they receive |
|---|---|---|
| Control (Group 1) | Active comparator | Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention. Receives: Behavioral: Control Intervention |
| NNS Restriction in Lactation (Group 2) | Active comparator | Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation. Receives: Behavioral: NNS Restriction Intervention; Behavioral: Control Intervention |
| NNS Restriction in Pregnancy and Lactation (Group 3) | Active comparator | Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation. Receives: Behavioral: NNS Restriction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants' adiposity
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.
Measured: At 6 months of age
Mothers' incremental area under glucose response curves
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.
Measured: At 28 weeks gestation
Secondary outcomes (16)
Infants' adiposity
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.
Measured: At 1 month of age
Mothers' fasting blood glucose concentration
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
Measured: At 28 weeks gestation
Mothers' fasting blood glucose concentration
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
Measured: At 1 month postpartum
Mothers' fasting blood glucose concentration
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
Measured: At 6 months postpartum
Mothers' 60 minute glucose concentration
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the blood glucose levels 60 minutes following ingestion of a standard glucose/water mixture
Measured: At 28 weeks gestation
Mothers' 120 minute glucose concentration
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the blood glucose levels 120 minutes following ingestion of a standard glucose/water mixture.
Measured: At 28 weeks gestation
Infants' gestational age
Determine gestational age at birth.
Measured: At birth
Infants' birthweight
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight.
Measured: At birth
Infants' birthweight based on gestational age
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight for gestational age.
Measured: At birth
Infants' age-sex specific percentile
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' height and weight for age by assessing age-sex specific percentile.
Measured: At 1 month of age
Infants' age-sex specific percentile
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' height and weight for age by assessing age-sex specific percentile.
Measured: At 6 months of age
Mothers' insulin sensitivity index
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on maternal insulin sensitivity by assessing composite whole-body insulin sensitivity index (WBISI).
Measured: At 28 weeks gestation
Mothers' assessment of insulin resistance
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on maternal insulin sensitivity by assessing homeostasis model assessment of insulin resistance (HOMA-IR).
Measured: At 28 weeks gestation
Mothers' energy intake
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during pregnancy.
Measured: At 28 weeks gestation
Mothers' energy intake
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.
Measured: At 1 month postpartum
Mothers' energy intake
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.
Measured: At 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start19 Aug 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, Children's National Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Allison Sylvetsky (Meni), George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548828
- Sponsor's protocol ID
- SweetPea
- Other IDs
- R01HD107427
- Status last verified
- Feb 2026
- First submitted
- 1 May 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
- ClinicalTrials.gov ID
- NCT06548828
- Acronym / sponsor ID
- SweetPea
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
- Keywords
- Non-nutritive sweeteners (NNS), Pregnancy, Lactation, Infant fat mass, Gestational diabetes (GDM), Glucose tolerance, PeaPod
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, Children's National Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Group 1) | Active comparator | Behavioral: Control InterventionParticipants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention. |
| NNS Restriction in Lactation (Group 2) | Active comparator | Behavioral: NNS Restriction Intervention, Behavioral: Control InterventionParticipants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation. |
| NNS Restriction in Pregnancy and Lactation (Group 3) | Active comparator | Behavioral: NNS Restriction InterventionParticipants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnant
- ≤ 16 weeks gestation
- Singleton pregnancy
- Report frequent NNS beverage consumption (≥ 7 servings/week)
- 18-45 years of age
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNS Restriction InterventionDiscuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health. Provide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS. Emphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead. Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages. Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS | Behavioural | NNS Restriction in Lactation (Group 2), NNS Restriction in Pregnancy and Lactation (Group 3) |
| Control InterventionCounsel about best practices for home safety and babyproofing. Provide a detailed booklet to take home, which will provide information about home safety and baby proofing. Educate about common causes of accidental infant and young child injuries or death. Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing. | Behavioural | Control (Group 1), NNS Restriction in Lactation (Group 2) |
Primary outcome
Infants' adiposity
Time frame: At 6 months of age
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.
Mothers' incremental area under glucose response curves
Time frame: At 28 weeks gestation
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.
16 secondary outcomes
Infants' adiposity
Time frame: At 1 month of age
Mothers' fasting blood glucose concentration
Time frame: At 28 weeks gestation
Mothers' fasting blood glucose concentration
Time frame: At 1 month postpartum
Mothers' fasting blood glucose concentration
Time frame: At 6 months postpartum
Mothers' 60 minute glucose concentration
Time frame: At 28 weeks gestation
Mothers' 120 minute glucose concentration
Time frame: At 28 weeks gestation
Infants' gestational age
Time frame: At birth
Infants' birthweight
Time frame: At birth
Infants' birthweight based on gestational age
Time frame: At birth
Infants' age-sex specific percentile
Time frame: At 1 month of age
Infants' age-sex specific percentile
Time frame: At 6 months of age
Mothers' insulin sensitivity index
Time frame: At 28 weeks gestation
Mothers' assessment of insulin resistance
Time frame: At 28 weeks gestation
Mothers' energy intake
Time frame: At 28 weeks gestation
Mothers' energy intake
Time frame: At 1 month postpartum
Mothers' energy intake
Time frame: At 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NNS Restriction Intervention in people with Gestational Diabetes Mellitus in Pregnancy and Glucose Intolerance During Pregnancy, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison C Sylvetsky, PhD (202-994-5602, asylvets@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infants' adiposity (time frame: At 6 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.