Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06548828

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Behavior Breast Feeding Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance During Pregnancy Glucose Metabolism Disorders Metabolic Diseases Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location status: Recruiting

Location contact

Allison C Sylvetsky, PhD

CONTACT

[email protected]

202-994-5602

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNS Restriction Intervention

Behavioral

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 Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Infants' gestational age

    Time frame: At birth

    Determine gestational age at birth.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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).

  14. 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.

  15. 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.

  16. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison C Sylvetsky, PhD

CONTACT

[email protected]

202-994-5602

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Children's Hospital Los Angeles
  • Children's National Research Institute
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 12, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.