Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes

February 16, 2026 updated by: Allison Sylvetsky (Meni), George Washington University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Allison C Sylvetsky, PhD
  • Phone Number: 202-994-5602
  • Email: asylvets@gwu.edu

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • The George Washington University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control (Group 1)
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.
Behavioral: Control Intervention

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.
Active Comparator: NNS Restriction in Lactation (Group 2)
Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
Behavioral: Control Intervention

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.

Behavioral: NNS Restriction Intervention

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
Active Comparator: NNS Restriction in Pregnancy and Lactation (Group 3)
Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.
Behavioral: NNS Restriction Intervention

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 6 months of age
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.
At 28 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infants' adiposity
Time Frame: At 1 month 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.
At 1 month of age
Mothers' fasting blood glucose concentration
Time Frame: At 28 weeks gestation
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
At 28 weeks gestation
Mothers' fasting blood glucose concentration
Time Frame: At 1 month postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
At 1 month postpartum
Mothers' fasting blood glucose concentration
Time Frame: At 6 months postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
At 6 months postpartum
Mothers' 60 minute glucose concentration
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 blood glucose levels 60 minutes following ingestion of a standard glucose/water mixture
At 28 weeks gestation
Mothers' 120 minute glucose concentration
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 blood glucose levels 120 minutes following ingestion of a standard glucose/water mixture.
At 28 weeks gestation
Infants' gestational age
Time Frame: At birth
Determine gestational age at birth.
At birth
Infants' birthweight
Time Frame: At birth
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight.
At birth
Infants' birthweight based on gestational age
Time Frame: At birth
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.
At birth
Infants' age-sex specific percentile
Time Frame: At 1 month of age
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.
At 1 month of age
Infants' age-sex specific percentile
Time Frame: At 6 months of age
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.
At 6 months of age
Mothers' insulin sensitivity index
Time Frame: At 28 weeks gestation
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).
At 28 weeks gestation
Mothers' assessment of insulin resistance
Time Frame: At 28 weeks gestation
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).
At 28 weeks gestation
Mothers' energy intake
Time Frame: At 28 weeks gestation
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during pregnancy.
At 28 weeks gestation
Mothers' energy intake
Time Frame: At 1 month postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.
At 1 month postpartum
Mothers' energy intake
Time Frame: At 6 months postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.
At 6 months postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infants' gut microbiome composition
Time Frame: At 1 month of age
Determine the effects of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation on the composition of the infant gut microbiome as it changes dramatically over the first few years of life by evaluating relative abundance of Firmicutes, Akkermansia muciniphila, Bifidobacterium, Lactobacillus, Proteobacteria present in stool specimens.
At 1 month of age
Infants' gut microbiome composition
Time Frame: At 6 months of age
Determine the effects of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation on the composition of the infant gut microbiome as it changes dramatically over the first few years of life by evaluating relative abundance of Firmicutes, Akkermansia muciniphila, Bifidobacterium, Lactobacillus, Proteobacteria present in stool specimens.
At 6 months of age
Mothers' gestational weight gain
Time Frame: At delivery
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' total weight gain during pregnancy by assessing maternal gestational weight gain (GWG).
At delivery
Mothers' waist circumference
Time Frame: At 1 month postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' adiposity by assessing waist circumference (WC).
At 1 month postpartum
Mothers' waist circumference
Time Frame: At 6 months postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' adiposity by assessing waist circumference (WC).
At 6 months postpartum
Mothers' body composition during pregnancy
Time Frame: At 28 weeks gestation
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' body composition by assessing percent body fat.
At 28 weeks gestation
Mothers' C-reactive protein (CRP) concentration
Time Frame: At 28 weeks gestation
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations.
At 28 weeks gestation
Mothers' C-reactive protein (CRP) concentration
Time Frame: At 1 month postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations.
At 1 month postpartum
Mothers' C-reactive protein (CRP) concentration
Time Frame: At 6 months postpartum
Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations.
At 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's National Research Institute
Children's Hospital Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SweetPea
  • R01HD107427 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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